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Surname, Initial(s). (2012) Title of the thesis or dissertation. PhD. (Chemistry)/ M.Sc. (Physics)/ M.A. (Philosophy)/M.Com. (Finance) etc. [Unpublished]: University of Johannesburg. Retrieved from: https://ujcontent.uj.ac.za/vital/access/manager/Index?site_name=Research%20Output (Accessed: Date).

The effect of Allium cepa 12% hydrogel on the appearance of Caesarean Section scars

A research dissertation presented to the

Faculty of Health Sciences, University of Johannesburg,

as partial fulfilment for the

Master‟s Degree in Technology: Homoeopathy

by:

Alicia Gerber

200912559

Supervisor: _____________________________ Date: _________________

Dr Neil Gower

MTech Hom (UJ) CML (UNISA)

Co-supervisor: ______________________________ Date: _________________

Dr TebogoTsele-Tebekang

MTech Hom (UJ)

i

DECLARATION

I, Alicia Gerber declare that this is my own unaided work. This research dissertation is being

submitted for the degree of Master‟s in Technology: Homoeopathy at the University of

Johannesburg. It has not been previously submitted at any degree or examination at any other

Technikon or University.

_____________________________ _________________

Alicia Gerber Date

ii

iii

ABSTRACT

A scar is a replacement of normal structures by fibrous tissue at the site of injury. Scarring

following surgery or injury is difficult to predict and both physicians and their patients are highly

concerned with minimizing scar appearances, even small improvements in scarring would add

value. A total of 100 million patients develop scars in the developed countries alone each year as

a result of 55 million elective operations and 45 million operations after trauma. In South Africa

the Caesarean Sections (CS) delivery rate is 20.6%, substantially above the accepted WHO of

10-15%. Conventional clinical treatments of scars are often associated with a need for multiple

therapeutic sessions as well as a number of side effects.

The study aimed to assess the effect of 12% (v/v) Allium cepa Mother Tincture (MT) in a

hydrogel solution on the appearance of caesarean section scars using the Patient and Observer

Scar Assessment scale (POSAS) and digital photographical evidence. A group of 40 females

completed the study and were between the ages of 18 and 50. Participants were divided into 2

groups of 20 participants each. The study followed a controlled study format and was conducted

over four consultations, four weeks apart, over a twelve week period (W0; W4; W8 and W12).

Participants were evaluated at each consultation with the POSAS as well as photographic

documentation. It has been demonstrated that the POSAS scale is a reliable and valid scale and

provides a unidimensional measure for scar quality. It appears to be the most comprehensive

assessment scale by taking into account the patient‟s assessment of their own scar.

The results of the POSAS showed that both hydrogel (control) and hydrogel medicated by

Allium cepa (12%) (treatment) were able to improve the general appearance of scars in all

parameters measured except for sensations of pain and itching. Allium cepa (12%) compared to

the control hydrogel, appeared to significantly improve the patient‟s own perception of scar

stiffness, thickness and overall opinion thereof. Even thought there was a lack of significant

difference between groups, Allium cepa (12%) appears to improve the vascularity, thickness,

relief, pliability, surface area and colour of scars to a greater extent than the control hydrogel and

it is evident that more research over a longer period of time is required.

It was concluded from this study that 12% Allium cepa in hydrogel was found to be effective on

the appearance of Caesarean Section scars and may be used in the construction of further

research studies.

iv

The conclusion or results of this study may not be quoted for use or proof of efficacy nor

substantiation of any context without the express permission of the Department of Homoeopathy,

University of Johannesburg.

v

DEDICATION

“And whatever you do, whether in word or deed, do it all in the name of the Lord Jesus, giving

thanks to God.” Colossians 3:17

I dedicate this work to my inspiring parents, Louis and Amori Gerber, who has provided me with

all the love and encouragement needed to complete this, although the support sometimes needed

a passport. To my fiancé: Liam Smit, thank you for your inspiration, support and encouragement

along the way.

vi

ACKNOWLEDGEMENTS

There are a number of people without whom this dissertation might not have been written, and to

whom I am greatly indebted:

Dr Neil Gower Thank you for always finding time in your very busy schedule and

for the effort and patience spent on this dissertation. It was a

privilege to have you supervise this study.

Dr Tebogo Tsele Tebokang Thank you for all your kindness, time, quick responses and

understanding throughout this time.

Juliana van Staden For providing all the statistical guidance for the analysis of this

study.

Fusion Homoeopathics For manufacturing the medication used in the implementation of

the study.

All study participants This study could never have been completed without your

dedicated participation, belief and patience.

vii

TABLE OF CONTENTS

TITLE PAGE

DECLARATION

ABSTRACT

DEDICATION

ACKNOWLEDGEMENTS

TABLE OF CONTENTS

LIST OF APPENDICES

LIST OF FIGURES

LIST OF TABLES

CHAPTER ONE

Page

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xii

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INTRODUCTION 1

1.1 Problem statement

1.2 Aim of study

1.3 Benefits of study

1.4 Hypothesis

1.5 Null Hypothesis

CHAPTER TWO

LITERATURE REVIEW

1

1

1

2

2

3

2.1 Introduction

2.2 Anatomy of skin

2.3 Formation of scars

2.3.1 Wound healing

2.3.1.1 Haemostatic, inflammatory and migratory phase

2.3.1.2 Proliferation phase

2.3.1.3 Maturation phase

2.3.2 Primary and secondary wound healing

2.4 Factors that influence wound healing

2.4.1 Age

2.4.2 Oestrogen

2.4.3 Infection

3

4

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viii

2.4.4 Diabetes Mellitus

2.4.5 Nutritional deficiencies

2.4.6 Obesity

2.4.7 Alcohol

2.4.8 Defective collagen synthesis

2.4.9 Genetic predisposition

2.5 Classification of scars

2.5.1 Non hypertrophic scars (NHS)

2.5.2 Fibro proliferative scars (FPS)

2.5.3 Facial atrophic post acne scars (FAPS)

2.5.4 Burn scars

2.6 Scars of Caesarean delivery

2.6.1 Subumbilical midline

2.6.2 Pfannenstiel

2.7 Assessment of scars

2.7.1 Appearance

2.7.2 Physical characteristics

2.7.3 Patient‟s symptoms

2.8 Conventional and current treatment of scars

2.8.1 Pressure therapy

2.8.2 Silicone gel sheeting

2.8.3 Intralesional corticosteroid treatment

2.8.4 Cryotherapy

2.8.5 Laser therapy

2.8.6 Radiotherapy

2.8.7 Vitamin A

2.8.8 Vitamin E

2.8.9 Bio-oil®

2.9 Homoeopathy

2.9.1 Homoeopathic mother tinctures

2.9.2 Allium cepa mother tincture

2.10 Hydrogel

2.11 Related research

10

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CHAPTER THREE

METHODOLOGY

3.1 Introduction

3.2 Research design

3.3 Research sample size

3.3.1 Inclusion criteria

3.3.2 Exclusion criteria

3.4 Research procedure

3.5 Medication administration

3.6 Reliability and validity

3.7 Data collection and analysis

CHAPTER FOUR

RESULTS

4.1 Introduction

4.2 Participant recruitment

4.3 Demographic data analysis

4.3.1 Age distribution

4.3.2 Number of previous CS

4.4 POSAS Observer scale

4.4.1 Vascularity

4.4.2 Pigmentation

4.4.3 Thickness

4.4.4 Relief

4.4.5 Pliability

4.4.6 Surface area

4.4.7 Overall opinion of Observer

4.5 POSAS Patient scale

4.5.1 Pain

4.5.2 Itching

4.5.3 Colour

4.5.4 Stiffness

4.5.5 Thickness

4.5.6 Irregularity

24

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x

4.5.7 Overall opinion of participant

4.6 Digimizer®

4.6.1 Surface area of scar

4.6.2 Length

4.6.3 Width

CHAPTER FIVE

DISCUSSION

5.1 Introduction

5.2 Demographic data discussions

5.2.1 Age distribution

5.2.2 Number of previous CS

5.3 POSAS Observer scale

5.3.1 Vascularity, pigmentation, thickness, relief and surface area

5.3.2 Pliability

5.3.3 Overall opinion

5.4 POSAS Patient scale

5.4.1 Pain

5.4.2 Itching

5.4.3 Colour

5.4.4 Stiffness

5.4.5 Thickness

5.4.6 Irregularity

5.4.7 Overall opinion

5.5 Digimizer®

5.5.1 Surface area and Length

5.5.2 Width

5.6 Summary of results

5.6.1 POSAS Observer scale

5.6.2 POSAS Patient scale

5.6.3 Digimizer®

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CHAPTER SIX

CONCLUSION AND RECOMMENDATIONS

6.1 Conclusion

6.2 Recommendations

REFERENCES

LIST OF APPENDICES

APPENDIX A

Advertisement

APPENDIX B

Participant information form

APPENDIX C

Consent Form

APPENDIX D

Case Taking Form

APPENDIX E

POSAS Observer and Patient Scale

APPENDIX F

STATKON statistics tables

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xii

LIST OF FIGURES

Figure Title Page

Figure 2.1 Anatomy of skin 4

Figure 2.2 Layers of epidermis 5

Figure 2.3 Wound healing 7

Figure 4.1 CONSORT flow diagram 29

Figure 4.2 Number of previous CS in control group 31

Figure 4.3 Number of CS in treatment group 32

Figure 4.4 POPAS observer scale - Vascularity 33

Figure 4.5 POSAS observer scale – Pigmentation 35

Figure 4.6 POSAS observer scale – Thickness 37

Figure 4.7 POSAS observer scale – Relief 38

Figure 4.8 POSAS observer scale – Pliability 40

Figure 4.9 POSAS observer scale – Surface area 42

Figure 4.10 POSAS observer scale – Overall opinion 43

Figure 4.11 POSAS patient scale – Pain 45

Figure 4.12 POSAS patient scale – Itching 47

Figure 4.13 POSAS patient scale – Colour 48

Figure 4.14 POSAS patient scale – Stiffness 50

Figure 4.15 POSAS patient scale – Thickness 51

Figure 4.16 POSAS patient scale – Irregularity 53

Figure 4.17 POSAS patient scale – Overall opinion 55

Figure 4.18 Digimizer® - Surface area 57

Figure 4.19 Digimizer® - Length 58

Figure 4.20 Digimizer® - Width 60

Figure 5.1 Percentage improvements in POSAS Observer scale 71

Figure 5.2 Percentage improvements in the POSAS Patient scale 72

Figure 5.3 Digimizer® percentage improvements 73

xiii

LIST OF TABLES

Table Title Page

Table 4.1 Age distribution 30

Table 4.2 Number of previous CS 31

Table 4.3 Friedman test – Vascularity 33

Table 4.4 Wilcoxon Signed Ranks test – Vascularity 34

Table 4.5 Mann-Whitney U test – Vascularity 33

Table 4.6 Friedman test – Pigmentation 35

Table 4.7 Wilcoxon Signed Ranks test – Pigmentation 35

Table 4.8 Mann-Whitney U test – Pigmentation 36

Table 4.9 Friedman test – Thickness 37

Table 4.10 Wilcoxon Signed Ranks test – Thickness 37

Table 4.11 Mann-Whitney U test – Thickness 38

Table 4.12 Friedman test –Relief 39

Table 4.13 Wilcoxon Signed Ranks test – Relief 39

Table 4.14 The Mann-Whitney U test – Relief 39

Table 4.15 Friedman test - Pliability 40

Table 4.16 Wilcoxon Signed Ranks test – Pliability 40

Table 4.17 Mann-Whitney U test – Pliability 41

Table 4.18 Friedman test – Surface area 42

Table 4.19 Wilcoxon Signed Ranks test – Surface area 42

Table 4.20 Mann-Whitney U test – Surface area 43

Table 4.21 Friedman test – Overall opinion 44

Table 4.22 Wilcoxon Signed Ranks test – Overall opinion 44

Table 4.23 Mann-Whiney U test – Overall opinion 44

Table 4.24 Friedman test – Pain 45

Table 4.25 Mann-Whitney U test – Pain 45

Table 4.26 Friedman test – Itching 47

xiv

Table 4.27 Mann-Whitney U test – Itching 47

Table 4.28 Friedman test – Colour 48

Table 4.29 Wilcoxon Signed Ranks test – Colour 49

Table 4.30 Mann-Whitney U test – Colour 49

Table 4.31 Friedman test – Stiffness 50

Table 4.32 Wilcoxon Signed Ranks test – Stiffness 50

Table 4.33 Mann-Whitney U test – Stiffness 51

Table 4.34 Friedman test – Thickness 52

Table 4.35 Wilcoxon Signed Ranks test – Thickness 52

Table 4.36 Mann-Whitney U test – Thickness 52

Table 4.37 Friedman test – Irregularity 53

Table 4.38 Wilcoxon Signed Ranks test – Irregularity 54

Table 4.39 Mann-Whitney U test – Irregularity 54

Table 4.40 Friedman test – Overall opinion 55

Table 4.41 Wilcoxon Signed Ranks test – Overall opinion 55

Table 4.42 Mann-Whitney U test – Overall opinion 55

Table 4.43 Friedman test – Surface area 57

Table 4.44 Wilcoxon Signed Ranks test – Surface area 57

Table 4.45 Mann-Whitney U test – Surface area 58

Table 4.46 Friedman test – Length 59

Table 4.47 Wilcoxon Signed Ranks test – Length 59

Table 4.48 Mann-Whitney U test – Length 59

Table 4.49 Friedman test – Width 60

Table 4.50 Wilcoxon Signed Ranks test – Width 61

Table 4.51 Mann-Whitney U test – Width 61

1

CHAPTER ONE

INTRODUCTION

1.1 Problem statement

In South Africa the Caesarean Sections (CS) delivery rate is 20.6%, substantially above the

accepted WHO rate of 10-15% (Gibbons et al., 2012). These surgical wounds can result in

normal asymptomatic scars or scars that are cosmetically dysfunctional, causing pain, itching,

discomfort, contracture, stigmatisation and loss of self-esteem leading to diminished quality of

life and other functional impairment (Zurada et al., 2006). A survey has shown that patients are

dissatisfied with scars on both visible and non-visible body sites and would value any

opportunity to improve or minimise scarring following surgery (Young and Hutchison 2009).

Various conventional clinical treatments of scars are often associated with a need for multiple

therapeutic sessions as well as a number of side effects such as an increased risk of infection,

potential pigmentation alterations, epidermal thickening, epidermal erythema and a lengthy

recovery period (Chapas et al., 2008).

A pilot research study in Thailand has been conducted on the effectiveness of onion extract gel

on surgical scars and yielded positive results with regards to scar height and associated

symptoms (Chanprapaph et al., 2012). There is no clinical evidence as yet for the use of topical

application of homoeopathically prepared 12% Allium cepa MT in a Hydrogel preparation on CS

using the Patient and Observer Scar Assessment Scale (POSAS) and photographic

documentation (van der Kar et al., 2005).

1.2 Aim of study

The aim of the study is to determine the effect of 12% (v/v) Allium cepa MT in a hydrogel

solution on the appearance of caesarean section scars using the POSAS and digital

photographical evidence.

1.3 Benefits of study

This study may show that the homoeopathic tincture and hydrogel combination is effective in

improving the appearance of CS scars. If positive results are obtained, it might yield the

availability of an effective topical application for CS scars and may later contribute to further

research in the treatment of other forms of skin scarring.

2

1.4 Hypothesis

The hypothesis is that homoeopathic Allium cepa MT mixed in a hydrogel solution will improve

appearance of CS scars.

1.5 Null Hypothesis

The null hypothesis states that homoeopathic Allium cepa MT mixed in a hydrogel solution will

show no statistical significance between the control group and the treatment group.

3

CHAPTER TWO

LITERATURE REVIEW

2.1 Introduction

Healthy and attractive skin plays a major role in most individual‟s self-esteem, and it is the key

component of the image they present to the outside world. The appearance, texture and physical

qualities of the skin play a substantial role in most grooming behaviours. People with skin

conditions are often stigmatised and population prevalence studies reveal a vast burden of

undiagnosed, untreated skin conditions (Colledge et al., 2010).

A scar is a replacement of normal skin structures by fibrous tissue at the site of injury (Colledge

et al., 2010). Scarring following surgery or injury is difficult to predict. Both physicians and their

patients are very concerned with minimizing scar appearance and value even small

improvements in scarring (Gaulgitz et al., 2011). A total of 100 million patients develop scars in

the developed countries alone each year as a result of 55 million elective operations and 45

million operations after trauma (Sund, 2000).

Dermal wounds that lead to scars can occur intentionally as a result of surgical measures or

accidentally from skin injury. In either case, both patient and physician desire to see wound

healing with insignificant scar formation. Accordingly, any scientifically pharmacological or

physical intervention that can improve scar appearance is of significant value (Draelos et al.,

2012).

While scars are considered less important than other types of life-threatening diseases, these

treatment resistant scars can have a significant impact on quality of life and are sometimes are

life-threatening by making the patient suicidal (Cotterelli and Cunliffe, 1997). Although many

different treatments have been utilized to improve the negative impact of scars on individuals,

degrees of success have not been consistent (Alster et al., 2007)

Studies of scar treatments to date are limited for a number of reasons. Studies that do not apply

different methods of scar assessment are making it difficult to evaluate the precise effects of each

topical treatment, whereas other studies use different control protocols, such as no treatment or

palliative massage. Another long-standing issue has been the difficulty to quantitatively measure

certain subjective scar parameters, such as colour, induration or pruritus.

4

Given the long-term duration and nature of scar treatment, patient compliance has also been

problematic (Zurada, 2006).

Based on the recently published German guidelines on scarring, onion extract containing scar

creams can be considered as additional therapy for active hypertrophic scars and for post-

surgical prophylaxis of excessive scarring (Nast et al., 2012).

2.2 Anatomy of skin

The skin is the largest organ in the human body and covers a surface area of about two square

metres in an average adult. The major functions of the skin are: protecting underlying organs or

tissues; assisting in the excretion of waste and maintaining normal body temperature;

synthesising vitamin D; storing nutrients; detecting pressure, pain, touch and temperature

(Colledge et al., 2010; Martini and Nath, 2009). The skin is composed of three layers: the

epidermis, the dermis and the subcutaneous tissue layer (hypodermis) (Colledge et al., 2010):

Figure 2.1 Anatomy of skin (Martini and Nath, 2009)

Epidermis: The epidermis is composed of superficial stratified squamous epithelium; it is the

outmost layer of the skin and is primarily composed of keratinocytes. Keratinocytes

synthesise a variety of structural proteins that play the main role in maintaining normal

cutaneous functioning. The epidermis is continually replacing itself and this is even more

evidential in the event of injury (Colledge et al., 2010).

5

The epidermis is attached to, but separated from, the dermis by the basal layer (Colledge et

al., 2010). This is an avascular layer that is nourished by the vascularised dermis (Moore et

al., 2010). Three other cell types that make up the remaining epidermal cells are langerhans

cells, melanocytes and merkel cells. Langerhans cells circulate between the epidermis and

local lymph nodes. Their main function is to present foreign pathogens to lymphocytes.

Melanocytes are primarily found in the basal layer, synthesizing melanin and transferring

them to surrounding keratinocytes. Merkel cells are also found in the basal layer and play a

role in sensation of fine touch (Colledge et al., 2010).

The structure of the epidermis is made up of five less distinct sub-layers namely: the stratum

corneum, the stratum lucidum, the stratum granulosum, the stratum spinosum and the stratum

basale (Hill, 2006).

Figure 2.2 Layers of Epidermis (Brannon, 2007)

The stratum corneum is the most superficial layer and the thickness varies throughout the

body. The stratum lucidum is a band of thin, clear, closely packed cells which is more

prominent in areas of thick skin. The stratum granulosum has cells that are granular and

becomes flatter when moving up to the stratum corneum. Cells in the stratum spinosum are

intertwined with tiny structures called desmosomes. Desmosomes allow for materials to

move through the interspaces. The stratum basale is the basement of the epidermis anchoring

the epidermis to the dermis. Cells of regeneration for all the sub layers of the epidermis are

contained within this layer (Hill, 2006).

Dermis: The dermis is a vascular layer that supports the epidermis nutritionally and

structurally. It is supplied by arteries that enter a deep cutaneous plexus of anastomosis,

6

while afferent nerve endings supply the skin with sensations of pain, temperature and

pressure. Most nerve endings are in the dermis, while few penetrate the epidermis (Moore et

al., 2010).

The dermis is a dense layer of interweaving collagen and elastic fibres, providing skin tone,

elasticity and account for the strength and toughness of skin. The bundles of collagen fibres

in the dermis run in all directions to a produce a tough felt-like tissue, in any specific location

most fibres run in the same direction. The predominant pattern of collagen fibres determines

the characteristic tension lines of the skin; therefore the skin is always in tension. Collagen I

and II, elastin and reticulin are synthesised by the major cell-type namely fibroblasts. Other

cells in the dermis include mast cells, mononuclear phagocytes, T-lymphocytes, dendritic

cells, nerves and blood vessels (Moore et al., 2010).

Subcutaneous tissue: Located between the dermis and underlying deep fascia, the

subcutaneous tissue is composed of loose connective tissue, stored fat, superficial blood

vessels, lymphatic vessels and sweat glands. The subcutaneous tissue‟s main function is

thermoregulation, providing insulation of heat (Moore et al., 2010).

2.3 Formation of scars

Medical terminology defines a scar as non-regenerative wound healing (Sarabahi and Tiwari,

2012).

2.3.1 Wound healing

Wound healing is a dynamic and complex physiological cascade with overlapping but distinct

phases to promote tissue repair. Clinically wound healing disorders result in hypertrophic scars

or non-healing wounds (ulcers). The phases of wound healing entail the haemostatic

inflammatory phase, the migratory phase, the proliferation phase and the maturation phase

(Martini and Nath, 2009).

7

Figure 2.3 Wound healing (Leaper and Haring, 1998)

2.3.1.1 Haemostatic, inflammatory and migratory phase

The inflammatory phase is the body‟s natural response to injury. Immediately after a wound has

formed platelet degranulation starts with the activation of the complement and clotting cascade

and a fibrin clot is formed (Slemp and Kirschner, 2006). Once haemostasis has been achieved,

vessels then dilate to allow essential cells including antibodies, white blood cells, growth factors,

enzymes and nutrients to reach the wounded area. Mast cells in the region trigger an

inflammatory response and leads to exudative oedema in the area. It is at this stage that the

characteristic signs of inflammation can be seen: erythema, heat, oedema, pain and functional

disturbance (Martini and Nath, 2009).

2.3.1.2 Proliferation phase

The proliferation phase of wound healing includes new blood vessel formation (angiogenesis),

collagen deposition, formation of granulation tissue, epithelisation and wound contraction

(Midwood et al., 2004). During the proliferation phase new granulation tissue is formed which is

comprised of collagen and extracellular matrix (ECM). The fibroblasts are responsible for

recruiting and producing a framework of ECM which leads to the structural outline of the wound

and allows vascular support to the area (Slemp and Kirschner, 2006). Healthy granulation tissue

is dependent upon the fibroblast receiving sufficient levels of oxygen and nutrients supplied by

the blood vessels. Granulation tissue is granular and uneven in texture; it does not bleed easily

and is pink or red in colour. The presence of granulation tissue is an indicator of wound healing.

During the healing of a surgical wound, epithelial cells migrate across the wound and form a

protective barrier within 24 hours, resembling the regular epidermis layer within 5 days.

8

The repair of skin continues for three to 14 days depending on the size and / or type of wound

(Martini and Nath, 2009).

2.3.1.3 Maturation phase

Maturation is the final phase and occurs once the wound has closed. This phase involves

remodelling of collagen from type III to type I. Cellular activity reduces and the number of blood

vessels in the wounded area decrease. Myofibroblasts initiate wound contracture. Once the

wound is closed, the immature scar transitions into the final maturation phase - this is where

excess ECM is broken down and immature type III collagen is matured and modified into type I

collagen (Slemp and Kirschner, 2006).

Throughout the repair of skin tissue after an injury, the epidermis is the first to heal and form a

protective cell layer under the scab while fibroblasts in the dermis continue to create granulation

and scar tissue that will gradually elevate the overlying epidermis (Martini and Nath, 2009).

Scars remain red and prominent for up to 8 weeks after trauma and only during the collagen

remodelling phase will the erythema and thickness begin to decrease (Porter and Kaplan, 2011).

As stated before, most bundles of collagen fibres in the specific area run in the same direction.

Lacerations or incisions that parallel the tension lines usually heal well with little scarring due to

minimal disruption of fibres. However, a laceration or incision across the tension lines disrupts

more collagen fibres. The disrupted lines of force cause the wound to part and it may heal with

excessive scarring (Moore et al., 2010).

Due to the skin‟s natural elasticity and underlying muscles, there are static forces on the skin.

When scar tissue forms it is not as strong as adjacent unharmed skin; these static forces tend to

widen the scar resulting in a cosmetically undesirable appearance after apparently satisfactory

wound closure (Porter and Kaplan, 2011).

2.3.2 Primary and secondary wound healing

By definition, primary wound healing involves a non-infected wound and uncomplicated healing

in a wound with clean edges and no loss of tissue. In this type of wound the three phases of

wound healing are completed without interruption and with minimal need for granulation tissue

formation. Secondary wound healing takes place in a wound with more severe tissue loss. This

type of healing involves generation of granulation tissue with epithelialisation over it.

9

Given the fact that angiogenesis and epithelialization take longer to form, these wounds are more

prone to infection, poor healing and scarring (Slemp and Kirschner, 2006).

2.4 Factors that influence wound healing/scar formation

Wound healing is a complex and highly coordinated process that results after injury. It is aimed

at restoring the integrity and function of the skin. Wound healing disorders present as

hypertrophic scars or non-healing wounds (Slemp and Kirschner, 2006). Scars can occur from

any dermal injury, taking into account these factors:

2.4.1 Age

Human skin like all other organs undergoes chronological aging and aging as a consequence of

environmental damage. Aging skin has a marked susceptibility to dermatologic disorders due to

the structural and physiologic changes that occur, leading to a decline in normal functions of the

skin and some inevitable changes (Durai et al., 2012). As skin ages, the vasculature

progressively atrophies and the supporting dermis also deteriorates, with collagen and elastin

fibers becoming sparse and increasingly disordered. With age the epidermal dermal junction

flattens and the interdigitations decrease leaving the skin thin with a decreased elasticity. There

is also a decrease in epidermal filaggrin resulting in dry and flaky skin, and the epidermal

turnover rate decreases by 50% with age. These changes, and a steadily decreasing ability to

effect skin repair, leave the elderly increasingly susceptible to skin injuries such as pressure

ulcers and skin lacerations (Farage et al., 2009).

2.4.2 Oestrogen

Many of the effects of oestrogen on the human skin have been described based on the changes

that are seen following menopause. The skin appears to act as the end-target for oestrogenic

action, therefore marked structural and functional changes to the skin occur postmenopausally.

Reduced oestrogen levels have significant negative effects on cellular and tissue responses to

injury (Ashcroft and Ashworth, 2003).The primary modulatory effects of oestrogen on wound

healing may occur during the inflammatory phase of healing. Although the manner by which

oestrogen exerts its anti-inflammatory effect is not well understood, it is hypothesized that it

mainly affects chemotaxis of polymorphonuclear leukocytes (PMN) via a receptor-mediated

mechanism. Beta-estradiol has been shown to suppress chemotaxis of PMN in a dose-dependent

manner and this suppressive effect on PMN chemotaxis has been shown to be inhibited by use of

anti-oestrogens. During the remodelling phase of wound healing, oestrogen can affect collagen

content, tensile strength, and macroscopic appearance of scar tissue (Oh and Phillips, 2006).

10

2.4.3 Infection

About 2-3% of surgical wounds are complicated by infection; the risk of infection is greatest

during the first 48 to 72 hours after injury. Persistent infection 2 weeks after injury results in

delayed epidermal maturation and is linked to increase scarring. Wound infection significantly

impairs and delays epidermal regeneration and maturation, resulting in greater dermal injury and

a deeper scar (Singer and McClain, 2002).

2.4.4 Diabetes mellitus

Diabetes mellitus increases the risk for major complications in wounds. Diabetes decreases

angiogenesis in the inflammatory wound healing phase resulting in impaired circulation to

tissues and subsequent reduced tissue oxygen perfusion. Diabetes has been shown to affect

immune system functions. Together with peripheral neuropathy, which predisposes the patient

to tissue trauma, an increased risk for infection arises. Collagen synthesis and accumulation

declines which diminishes the tensile strength of wounds and indicates a high risk of wound

dehiscence (Coursin et al., 2004).

2.4.5 Nutritional deficiencies

Protein, amino acids, fatty acids, minerals and vitamins are required for normal wound healing

(Meghan and Barbul, 2006). Deficiencies in the following nutritional substances may lead to

poor wound healing:

Protein: protein deficiency is one of the most important nutritional elements distressing

wound healing. A shortage of protein can impair capillary formation, fibroblast proliferation,

collagen synthesis, and wound remodelling which predisposes one to impaired wound

healing. A deficiency in protein affects the immune system, with a resultant increased

susceptibility to infection (Campos et al., 2008).

Vitamin C: vitamin C deficiencies result in impaired healing, and have been linked to

decreased collagen synthesis and fibroblast proliferation, decreased angiogenesis, and

increased capillary fragility. Also, vitamin C deficiency leads to an impaired immune

response and increased susceptibility to wound infection (Campos et al., 2008).

Vitamin A: the biological properties of vitamin A include anti-oxidant activity, increased

fibroblast proliferation and increased collagen synthesis. A deficiency in Vitamin A leads to

impaired wound healing (Burgess, 2008).

Glutamine: glutamine has a crucial role in stimulating the inflammatory phase in wound

healing. Oral glutamine supplementation has been shown to improve wound breaking

strength and to increase levels of mature collagen (da Costa et al., 2003).

11

2.4.6 Obesity

In obesity, an increase in complicated surgical site infections has been detected. This can be

explained by a relative hypo-perfusion in subcutaneous adipose tissue and a decreased delivery

of antibiotics as well. Wound tension increases tissue pressure, reducing micro-perfusion and the

availability of oxygen to the wound. In surgical wounds, the increased tension on the wound

edges that is frequently seen in obese patients also contributes to wound dehiscence (Radek et

al., 2007).

2.4.7 Alcohol

Exposure to ethanol influences the proliferative phase of wound healing. The most significant

impairment seems to be in wound angiogenesis, which is reduced by up to 61% following a

single ethanol exposure. The ethanol-mediated decrease in wound vascularity causes an oxygen

deprived state in wounds (hypoxia). Hypoxic wounds are prone to infections, impaired

angiogenesis, decreased keratinocyte differentiation, reduction in fibroblast proliferation,

collagen synthesis and have difficulty with wound contraction resulting in a bigger or deeper

scar (Radek et al., 2007).

2.4.8 Defective collagen synthesis

Ehlers-Danlos syndrome is due to a genetic defect in collagen and connective tissue synthesis

and structure. Affected individuals have velvety and soft skin that is highly elastic and delicate.

They tend to bruise easily and this condition also causes abnormal scarring. Ehlers-Danlos

syndrome causes wounds that split open with little bleeding and leave scars that widen over time

to create characteristic shallow "cigarette paper" scars (Eder et al., 2013).

2.4.9 Genetic predisposition

Current data propose a genetic susceptibility with a resilient immunogenic component to dermal

fibrosis together with major histocompatibility complex genes being associated could link

genetics to excessive skin scarring. According to data it appears unlikely that a single gene is

responsible for the development of raised dermal scars. A likely scenario may involve the

interaction of several gene pathways in addition to environmental factors (Brown and Bayat,

2009).

12

2.5 Classification of scars

Scars that arise from surgical wounds or any other dermal injury can be divided into four main

classes: non-hypertrophic (NHS), fibro-proliferative (FPS), facial atrophic post-acne scars

(FAPS) and burn scars (Lee, 2010):

2.5.1 Non-hypertrophic scars (NHS)

Non hypertrophic scarring includes scars that are not protruding such as atrophic scars and

textural scars; textural scars are flat or insignificantly elevated (Lee, 2010).

2.5.2 Fibro-proliferative scars (FPS)

Fibro-proliferative scars include protruding scars according to elevation of tissue which involves

hypertrophic scars and keloids (Lee, 2010). Hypertrophic scarring usually occurs within 4 to 8

weeks following wound infection, wound closure with excess tension or other distressing skin

injury. Hypertrophic scars have a rapid growth phase for up to 6 months, and then gradually

lapses over a few years, finally leading to flat scars with no additional symptoms. Hypertrophic

scars are usually linear. If following a surgical scar it can be papular or nodular with

inflammatory and ulcerating lesions (Hawkins, 2007).

Keloids, in contrast, may develop up to several years after minor injuries and may even form

unexpectedly without any known injury. Keloids appear as firm, mildly tender nodules with a

shiny surface and sometimes telangiectasia. The epithelium is thinned and there may be focal

areas of ulceration. The colour is pink to purple and may be accompanied by hyperpigmentation.

Both lesions are commonly pruritic, but keloids may even be the source of significant pain and

hyperesthesia (Hawkins, 2007).

2.5.3 Facial atrophic post-acne scars (FAPS)

This class of scars have a unique characteristic making it a separate entity; it consists of a cluster

of small pleomorphic atrophic scars congregated closely (Lee, 2010).

13

2.5.4 Burn scars

These have significantly different depth and areas, setting it apart from the rest of the groups

(Lee, 2010).

2.6 Scars of caesarean delivery

Caesarean Section (CS) delivery is defined as a surgical delivery by incision into the uterus

(Porter and Kaplan, 2011). CS delivery was introduced in clinical practice as a life-saving

procedure both for the mother and baby (Betrán et al., 2007).

The Caesarean delivery rate is increasing globally beyond the recommended accepted WHO

level of 10-15% (World Health Organisation, 2007). District hospitals in South Africa have a CS

rate of 16.1% (Day et al., 2011) while in 2008 the CS delivery rate for South Africa as whole

was reported to be 20.6% (Gibbons et al., 2012).

The type of CS incision is surgeon dependent and motivated by a variety of indications,

circumstances and the surgeon‟s level of skill (Mathai and Hofmeyer, 2007). CS uterine

incisions can be subumbilical midline (vertical) or Pfannenstiel (lower transverse/suprapubic).

Each surgical incision results in a dermal injury and a scar (Porter and Kaplan, 2011):

2.6.1 Subumbilical midline incision

Traditionally CS was performed by a midline vertical skin incision from the pubic symphysis to

umbilicus. The rectus muscle and peritoneum are then incised in the avascular midline.

Advantages of this method include speed and the ability to extend the incision upwards if

needed, and if local anaesthesia is to be used. The main disadvantage is the degree of post-

surgical scarring (Mathai and Hofmeyr, 2007).

In the National Guidelines for Maternity Care in South Africa, numerous indications for

subumbilical midline incisions are given. These include increased risk of intraoperative

haemorrhage such as eclampsia or anticipated difficult delivery, and prolonged labour or rupture

of membranes which could lead to an increased risk of postoperative infection. While the global

trend is towards transverse incisions, vertical incisions are still commonly performed in

developing countries (National Guidelines for Maternity Care in South Africa, 2002).

14

2.6.2 Pfannenstiel incision

The skin incision is a low transverse type, gently upward curving, following the natural skin fold

and located two finger breadths above the pubic symphysis. The underlying muscle is then

separated by blunt or sharp dissection from the fascia, ensuring haemostasis of the perforating

vessels. The rectus muscles are separated bluntly, before the peritoneum is entered sharply in the

midline exposing the uterus. Pfannenstiel incisions are associated with less post-operative pain

and earlier ambulation. The closure is more secured, there is less adipose tissue to incise and a

better cosmetic effect is also noted (Mathai and Hofmeyr, 2007).

South African patient and clinician preferences were recently evaluated by Rwakyendela and

Buchmann (2006). The study commenced in three state hospitals in Johannesburg, 400 patients

were interviewed in a cohort in whom 38% of women had vertical CS incisions and 62%

Pfannenstiel incisions. It was found that a majority of women would have chosen transverse

incisions if given the choice, thus preferring the cosmetically more acceptable Pfannenstiel type.

Clinicians who were interviewed trended towards the Pfannenstiel incision for elective CS

delivery (96%) and marginally favoured a midline incision for emergency CS.

Suturing plays an important role in primary wound healing and the tissue is held in proximity

until enough healing has occurred to withstand the stress without the mechanical support

provided by the sutures. Most common methods for mechanical wound closure in CSs involve

non-absorbable staples and absorbable subcutaneous sutures. Absorbable sutures provide

temporary wound support, until the wound heals to withstand the normal stress (Islam and

Ehsan, 2011). Non-absorbable staples are associated with an increased risk of skin separation,

potentially worsening the scar and the need for reclosure when compared with subcutaneous

absorbable sutures (Mackeen et al., 2012).

2.7 Assessment of scars

Accurate scar assessment is essential for diagnosing, managing and evaluating a therapeutic

strategy for scar management. Any comprehensive evaluation of scars involves measuring it on

three different dimensions, namely appearance, physical characteristics and patient symptoms.

2.7.1 Appearance

The anatomical location of the scar should be taken into account. Scar colour is determined by

the pigmentation and vascularity of the skin. Vascularity is defined as the presence of vessels in

scar tissue assessed by the amount of redness. Vascularity is tested by the amount of blood return

15

after blanching with a piece of Plexiglas. Scar pigmentation is the brownish colouration of the

scar caused by melanin and may be evaluated by applying Plexiglas to the skin with moderate

pressure to eliminate the effect of vascularity (Vercelli et al., 2009).

2.7.2 Physical characteristics

Scar thickness is defined as the average distance between the subcutical-dermal border and

the epidermal surface of the scar itself. The most accurate and reproducible method to

measure the overall scar thickness is through ultrasonography, while the protruding part can

be measured with a ruler (Van de Kar et al., 2005).

Relief signifies the extent of surface irregularities compared to adjacent normal skin. The

degree of irregularity can be reliably evaluated with subjective scales (Bloemen et al., 2011).

Pliability can be defined as the suppleness of the scar tested by wrinkling the scar between

the thumb and index finger (Van de Kar et al., 2005).

Surface area defines the area of the scar in relation to original wound area. The most

common method of measuring the surface area is planimetry through photography and

computer software analysis which can also be used to measure scar length and width.

Dizimizer®

software calculates length, width and surface area if calibration is provided (Van

de Kar et al., 2005).

2.7.3 Patient’s symptoms

Pain is the most common symptoms of scar healing. Commonly used terms in the description of

pain may include: „tender‟, „shooting‟, „sharp‟, „aching‟ and „heavy‟. Other symptoms like

stiffness and itching are also common. These assessments are performed with numerical rating

scales (Van Loey et al., 2007).

The Patient and Observer Scar Assessment Scale (POSAS) includes assessment of all three of

these dimensions and consists of both an Observer and a Patient Scale and includes a

comprehensive list of items, based on clinically relevant scar assessments. The observer scores

six items: vascularization, pigmentation, thickness, surface roughness, pliability, and surface

area. Each item is scored from 0-10, where 0 is “normal skin” and 10 is “worst scar imaginable”.

The patient scores six items: pain, pruritus, colour, thickness, relief, and pliability. Each item is

scored from 0-10 where 0 is “no / not at all‟ and 10 is yes / very much”. The scores for each

assessment are then totalled where a minimum score of 6 (normal skin) and maximum score of

60 (worst assessment) may be achieved (Vercelli et al., 2009).

16

The POSAS is a recognised, valid and reliable tool used for assessing scars. POSAS is

demonstrated with The Rasch model that it is a reliable and valid scale and provides an inclusive

measure for scar quality (Van der Wal et al., 2012). The POSAS appears the most

comprehensive taking into account the aspect of the patient‟s perspective (Vercelli et al., 2009).

POSAS have been recently validated for application on linear postsurgical scars and found that

both the Observer and Patient Scar Assessment Scale have good internal consistency

(Cronbach‟s alpha 0.74–0.90) (Truong et al.,2007; Van der Kar et al.,2005).

2.8 Conventional and current treatment of scars

Clinical interventions such as pressure therapy, silicone gel sheeting, intralesional corticosteroid

injection, cryotherapy, laser therapy and radiotherapy are associated with a number of side

effects such as an increased risk of infection, as well as potential pigmentation alterations,

epidermal thickness, epidermal erythema and a lengthy recovery period. These interventions

have limited accessibility, are not affordable to everyone and are also associated with a need for

multiple therapeutic sessions (Saray and Gulee, 2005; Chapas et al., 2008). Several over-the-

counter and prescription topical treatments are also used, including vitamin A, vitamin E and

Bio-oil ®

.

2.8.1 Pressure therapy

Pressure treatment is believed to quicken wound healing by numerous mechanisms, namely;

thinning of the dermis, decreasing oedema, and a reduction of blood flow and oxygen. The

garments are usually made from an elastic material with a high spandex content and are intended

to be worn over the area of injury for approximately 1 year until the scar completely heals.

Disadvantages of pressure therapy include its limited use in anatomic depressions, flexures, or

areas of high movement; patient discomfort; the need to be worn at all times; and occasional skin

ulceration from uneven pressure distribution. For these reasons, patient compliance can be a

major problem (Puzey, 2012).

2.8.2 Silicone gel sheeting

Silicone, a soft, semi-occlusive scar cover, is composed of cross-linked polydimethylsiloxone

polymer that is comparable to normal skin composition. Silicone gel sheeting is widely used to

minimize the size, induration, erythema, pruritus, and extensibility of pre-existing scars and to

prevent the formation of new scars (Gold et al., 2001). The mechanism of silicone gel sheeting

remains uncertain; studies have shown that silicone sheets do not change the pressure,

temperature, or oxygen level at the wound site. It is also believed that silicone sheets create a

17

hydrated, occluded environment that decreases capillary activity, thereby reducing fibroblast-

induced collagen deposition and scar hypertrophy. Most researchers believe that silicone sheets

decrease hyperaemia and lessen fibroblast production of collagen, thereby promoting wound

flattening (Chang and Ries, 2001).

2.8.3 Intralesional corticosteroid treatment

The effects of corticosteroids result primarily from their suppressive effects on the inflammatory

process in the wound and secondarily from reduced collagen and glycosaminoglycan synthesis,

inhibition of fibroblast growth as well as enhanced collagen and fibroblast degeneration (Reish

and Eriksson, 2008). To date, the use of intralesional triamcinolone acetonide (TAC) signifies

the therapy of choice for scars and effectively offers symptomatic relief by reducing pruritus.

Three to four injections of TAC (10–40 mg/mL) every 3–4 weeks are generally sufficient,

although occasionally injections continue for 6 months. Adverse events include dermal atrophy,

telangiectasia, and pain at the injection site (Nast et al., 2012).

2.8.4 Cryotherapy

Cryotherapy involves a probe that is connected to a cylinder of liquid nitrogen. A cryoneedle is

inserted into the scar and the liquid nitrogen causes the cryoneedle to freeze thereby freezing the

scar tissue from the inside out (Chanprapaph et al., 2012). Although cryotherapy is relatively

costly, it appears comparatively cost-effective, since frequently a single cryo-session is sufficient

to significantly improve scar tissue. Adverse effects are minimal with no worsening or infection

and only limited hypopigmentation was evident (Tziotzios et al., 2012)

2.8.5 Laser therapy

The most encouraging results have been demonstrated with the 585-nm pulsed dye laser (PDL).

PDL is believed to improve scar formation by inducing capillary destruction generating

hypoxaemia which in turn modifies local collagen production (Alster, 2003). Depending on the

energy density employed, vesicles and crusts may occur, purpura‟s can persist for 7-14 days and

longer persisting hyperpigmentation occurs particularly in darker skin types. Side effects such as

prickling sensations during treatment and post-treatment erythema may also occur (Leventhal et

al., 2006).

2.8.6 Radiotherapy

Radiotherapy gets its benefits through inhibition of neovascular buds and proliferating

fibroblasts, resulting in decreased collagen production. Superficial X-rays, electron beam and

18

low- or high-dose-rate brachytherapy have been employed primarily as an addition to surgical

removal of hypertrophic scars, with overall good results in terms of reduced recurrence

(Ragoowansi et al., 2003). Side effects include hypo- and hyperpigmentation, erythema,

telangiectasia and atrophy. Radiotherapy signifies some risks in terms of carcinogens, especially

in areas such as the breasts and thyroid; therefore it should be used with caution (Leventhal et

al., 2006).

2.8.7 Vitamin A

Vitamin A also known as retinoic acid is required to maintain healthy integrity of epithelial and

mucosal surfaces. A study observing daily application of 0.05% retinoic acid on hypertrophic

and keloid scars showed a reduction in the size of the scar, pruritus and caused scar softening,

flattening, and fading of hyperpigmentation or erythema of scar (Zurada et al., 2006). The

downside of vitamin A treatment involves the systemic absorption of topical retinoids.

Hypervitaminosis and teratogenicity are potential complications of this therapy, therefore

limiting its use, especially in pregnant females and people taking oral vitamin supplements

(Zurada et al., 2006).

2.8.8 Vitamin E

Vitamin E is a lipid-soluble antioxidant and has complex effects on wound healing. It has been

shown to penetrate into the dermis and reduce the formation of oxygen radicals that inhibit

healing and destruction to the DNA, cellular membranes, and lipids. Vitamin E also alters

collagen and glycosaminoglycan production and inhibits the spread of peroxidation of lipids in

cellular membranes, thereby acting as a membrane-stabilizing agent (Zurada et al., 2006).

However a high incidence (33%) of contact dermatitis is noted with Vitamin E usage (Baumann

and Spencer, 1999). The use of vitamin E in scar management has other theoretic limitations,

because of its ability to inhibit collagen synthesis. The use of vitamin E early in scar therapy may

reduce scar tensile strength and, thereby, lead to the development of widened scars and even

wound dehiscence (Widgerow et al., 2010).

2.8.9 Bio-oil®

Bio-Oil®

is the well-known golden standard skincare oil and claims to improve the appearance of

scars, stretch marks and uneven skin tone. It is the number one selling scar and stretch mark

product in 18 countries since its global launch in 2002. Bio-oil® contains the following

ingredients: Calendula officinalis, Lavandula angustifolia, Rosmarinus officinalis, Chamomile

oil, PurCellin, Vitamin A and Vitamin E combined together in a variety of oil bases. In 2010 the

19

efficacy of Bio-Oil® was assessed using the POSAS scar assessment scale on the improvement

of the appearance of scars. 36 participants between the ages of 18-65 were recruited in the study.

Results showed a statistically significant result after only 2 weeks (day 15), evident in 66% of

the subjects. After 8 weeks (day 57) 92% of subjects showed an improvement, with the extent of

the improvement almost triple that seen at 2 weeks (Zacher et al., 2013). The only obstacles to

the ingredients of Bio-oil are vitamin A due to potential hypervitaminosis (dosage dependant)

(Zurada et al., 2006).

2.9 Homoeopathy

The term homoeopathy is derived from two Greek words: homoios meaning similar and pathos

meaning suffering. The basic principle of Homoeopathy is similia similibus curentur or „Like

cures Like” – an illness should be treated by a substance capable of producing similar symptoms

to those being suffered by the patient (Ullman 2007). The method of homoeopathic preparation

involves a series of precise dilutions and succusions known as potentization (Aziz, 2010).

2.9.1 Homoeopathic mother tinctures

A homoeopathic MT is pharmaceutically prepared from a drug substance of the plant kingdom,

using alcohol as the solvent by the process of maceration and percolation. The drug to solvent

ratio quantity is a 1:10 v/v dilution (1D potency). A MT is the starting point for any

homoeopathic remedy (Owen, 2007).

2.9.2 Allium cepa mother tincture

Allium cepa is commonly known as the red onion and belongs to the Alliaceae family. In order

to make a homoeopathic mother tincture of Allium cepa, the bulb of the red onion is prepared

according to the method stipulated by the German homoeopathic pharmacoepeia (HAB 2A). In

this method the Allium cepa is cut up finely and added to 86% alcohol. This is left to stand for a

minimum of 10 days in a temperature not exceeding 20˚C (Owen, 2007).

Allium cepa as a tincture exhibits anti-inflammatory, bacteriostatic and collagen down-regulatory

properties. Quercetin, a bioflavonoid from Allium cepa, has shown antiproliferative effects on

both normal and malignant cells. In recent studies,quercetin has been shown to have an

inhibitory effect on the release of histamine, thereby relieving itching ofscars, as well as a noted

colour fade seen in scars (Hosnuter et al., 2007). These properties could theoretically prove

beneficial in reversing the inflammatory and proliferative responses (Bombaro et al., 2003;

Widgerow et al., 2010).

20

It is believed that the flavonoids (quercetin and kaempferol) in Allium cepa play a role in

reducing scar formation through inhibition of fibroblast activities (Phan et al., 2003). In 2010 an

in-vivo and in-vitro study was conducted in order to investigate the effect of Allium cepa and

quercetin on the proliferation of fibroblasts, the expression of type I collagen and matrix

metalloproteinase-1 (MMP-1). The data of the study show that proliferation rates of fibroblasts

were decreased in a dose-dependent manner with Allium cepa and quercetin. However the

expression of type I collagen was not markedly changed by the Allium cepa and quercetin.

Interestingly, the expression of MMP-1 was markedly increased by both Allium cepa and

quercetin in vitro and in vivo. Thus it can be concluded that the data indicate that Allium cepa

and quercetin play a role in the anti-scar effect in skin through up-regulation of MMP-1

expression, implying that that Allium cepa is a promising remedy for reducing of scar formation

(Cho et al., 2010).

Allium cepa is scientifically classed as a transforming growth factor beta 1(TGF ß1) antagonist is

the most important counteracting agonist in two wound healing phases. TGF ß1 plays a

significant role in the inflammatory phase and in the remodelling phase; the expression of TGF

ß1 causes increased fibroblast growth and excessive collagen synthesis which results in an

abnormal proliferation process. However, it is possible to prevent excessive fibroblast growth

through antagonizing PGF ß1. Therefore an effective anti-scarring agent has to have the essential

capacity to inhibit TGF ß1-activity in the late stage of wound healing. This effect can be used to

explain the efficacy of Allium cepa in the regulation of scarring processes (Ralf, 2007). Allium

cepa MT has been shown to improve collagen organization in the ears of rabbits (Saulis et al.,

2002).

Allium cepa is useful in reducing neoangiogenesis in hypertrophic scars and keloids, resulting in

the clinical improvement of skin vascularity (Draelos, 2008). It shows an anti-inflammatory

effect by inhibiting lipopolysaccharide-induced tumor-necrosis factor-alpha (TNF-α) production

(Hostner, 2013).

Based on the recently published German guidelines on scarring, onion extract-containing scar

creams can be considered as additional therapy for active hypertrophic scars and for post-

surgical prophylaxis of excessive scarring (Nast et al., 2012).

21

2.10 Hydrogel

As a route of administration, topical drug treatments generally allow for a direct and localised

effect of the active ingredient and therefore have fewer side effects compared to parenteral or

oral drug administration (Chen et al., 2012). The vehicle of topical treatments has other roles

besides containing the active ingredient; the vehicle can hydrate or soothe the skin and has

antimicrobial qualities (Colledge et al., 2010).

Hydrogel is a form of topical treatment. The term hydrogel defines a network of three-

dimensional structures capable of absorbing and retaining a significant amount of water (Gulrez

et al., 2011). Due to the significant content of water in hydrogel it retains a degree of flexibility

comparable to natural tissue. Hydrogel is mainly used in tissue engineering and in the

pharmaceutical and biomedical fields (Hoare and Kohane, 2008).

The standard thickness of skin is 2mm. When scar thickness reaches more than 4.91mm it is

classified as a hypertrophic scar. This makes the penetration of active compounds challenging.

With topical drug delivery systems (TDDS) the active compound must make contact with the

desired target area; however the thickness of the scar forms a strong barrier that prevents

penetration of the active compound to the target area (Tsang et al., 2007).

Due to the big differences in skin thickness, current treatment protocols for anti-scar treatment

are based on the standard vehicles such as creams, gels and ointments. The biggest challenge for

TDDS is to ensure effective penetration of drugs across the scar skin. Various formulations such

as microemulsions, liposomes, dendrimers, micro-sponges, solid lipid nanoparticles and

hydrogels have been reported for the advantages of biocompatibility (Chen et al., 2012).

These specific formulations are not only used as a vehicle but also play a role in drug reservoirs

that leads to a prolonged release of the active ingredient. A sustained release of the active

ingredient enhances the penetration across the scar skin (Chen et al., 2012). Gels have

hydrophilic and hydrophobic bases, used on specific sites like hair-bearing areas it is

cosmetically acceptable, reaching deeper layers more effectively and has a low risk of contact

sensitisation (Colledge et al., 2010).

2.11 Related research

A double-blind, randomised, split scar study was conducted in Thailand to determine the

effectiveness of onion extract gel on surgical scars in Asians (Chanprapaph et al., 2012).

22

Each half of the scar was randomly assigned to receive either unmedicated gel or gel medicated

with 12% Allium cepa. The results of the study showed a significantly improved difference in

mean scar height and mean scar symptoms between the control side and the treatment side at

week 4 and 12. Two limitations identified by the study included the small sample size and

absence of subjective measurement of the patient‟s overall satisfaction, improvement of social

participation and quality of life.

In North-Carolina a randomized, controlled, single-blinded study evaluated the appearance of 44

female participants with dermal scars after eight weeks of once-daily application of a onion

extract gel formulation compared to control (no application scars) in a dermatological surgical

setting. In 2012 the study concluded and published that once-daily application of the onion

extract gel improved their overall appearance, redness, softness, and smoothness of the scar

compared to control scars. In the majority of subjects, these benefits are apparent within 2 to 4

weeks of daily application and are fully defined after eight weeks (Draelos et al., 2012).

A clinical study in 2002 recruited 60 participants in order to evaluate the efficacy of topical

silicone derived onion extract gel on post-surgical sternotomy scars using the Vancouver scale.

The study was a randomized, placebo controlled, double-blinded study which took place over a

period of 12 treatment weeks in Bangkok. In both groups, application was carried out twice daily

and topical application was initiated at day 7 after surgery. During follow-up consultation (2

weeks) pain and itch was lower in the silicone derived Allium cepa extract gel group compared

to the control group. All parameters of Vancouver scar score assessment improved in the

treatment group, especially pigmentation. Hyperpigmentation faded significantly at all the time

points. A limitation to the study was that the faded colour change was observed visually but due

to subjective assessment (Vancouver scale) only, no definite conclusion could be made. Overall,

a plausible effect was observed for silicone derived onion extract gel in the prevention and

treatment of scar formation (Jenwitheesuk et al., 2012).

A comparative prospective study assigned 60 participants to three groups to assess the efficacy

of onion extract on hypertrophic and keloid scars. Group 1 was treated with onion extract alone,

group 2 with silicone gel sheet alone and group 3 with a combination of onion extract and

silicone gel sheet. In the group comparisons, a significant difference was observed at the end of

six months in the colour parameter between group 1 and group 2 and in the height parameter

between group 1 and group 3. The onion extract was more effective in relation to scar colour,

while the silicone gel sheet was superior in decreasing the height of scar. In addition, the most

23

effective therapeutic results were obtained when the silicone gel sheet treatment was combined

with onion extract in group 3. Onion extract improved hypertrophic and keloids scars via

multiple mechanisms. However, it was statistically ineffective in improving scar height and

itching (Hosnuter et al., 2007).

Jackson and Shelton evaluated the effectiveness of topical onion extract gel in improving the

appearance and symptoms of postsurgical scars compared to topical emollient in 17 subjects who

had undergone Mohs surgery, a precise surgery used in the treatment of skin cancer. Subjects

were divided into 2 groups: onion extract group and emollient group. Each group applied a

designated topical product 3 times a day for 4 weeks. No statistically significant difference was

found between pre and post-treatment evaluations of scar erythema and pruritus in patients using

topical onion extract gel. However, limitations included the small sample size, short treatment

duration and follow-up period (Jackson and Shelton, 2001).

Over the past decade, several studies have shown that onion extract applied 2 to 3 times a day for

periods of 3 to 6 months significantly improves the appearance of postsurgical scars, adhesions,

stretch marks, and hypertrophic scars in vitro and in vivo (Draelos, 2008; Viera et al., 2010). The

weight of evidence from these studies and the present data support the claim that onion extract is

beneficial in reducing the appearance of dermal scars when used as directed (Draelos et al.,

2012).

24

CHAPTER THREE

METHODOLOGY

3.1 Introduction

This chapter is used to explain the study design, participant recruitment, sample size and

treatment protocols.

3.2 Research design

This was a controlled study conducted over a period of 12 weeks utilising 40 participants. Due to

the nature of the associated odour of the medicated hydrogel it was not possible to guarantee

blinding of the researcher during the study. Participants were divided into 2 groups of 20

participants each.

3.3 Research sample size

The research sample consisted of 40 female participants that presented with a CS scar.

Participants were included regardless of the type of surgical scar (vertical or transverse).

Participants were recruited by way of advertisements (Appendix A) placed at UJ and various

medical facilities (paediatricians, gynaecologists, general practitioners and dermatologists) with

relevant permission granted.

3.3.1 Inclusion criteria

Individuals were included in the study if they:

Were female;

Were between the ages of 18-50 years;

Has had either a vertical or transverse surgical scar which was completed with subcutaneous

absorbable suturing; and

Were at least 8 weeks post-surgery.

3.3.2 Exclusion criteria

Individuals were excluded from participation in the study if they:

Had a history of onion allergy;

Used any other topical treatments for the CS scarring;

Had general surgical complications such as a fever, pain, increased perspiration, fatigue, or

signs of post-operative infections, or

25

Reported local surgical complications such as inflammation, infection, wound dehiscence,

sepsis, keloid scar formation and atrophic/hypertrophic scars.

3.4 Research procedure

This 12-week study was conducted at the Homoeopathy Health Centre, Doornfontein Campus,

UJ. At the first consultation (week 0) the study was explained thoroughly to all participants, the

researcher read through the information sheet including directions for medication use (Appendix

B) and the participant was requested to sign the consent form (Appendix C). A case taking form

(Appendix D) was then completed including an assessment of the impact of the scar on quality

of life. A brief physical exam (including Vital signs and CAJCOLD) was then conducted as for

follow up visits at week 4, 8 and 12, followed by the POSAS used to analyse the scar as well as

photographic documentation. Standardised photographs were taken under the same conditions at

each consultation. The images were stored electronically and a computer programme

(Digimizer®

) was used to accurately measure the scar and track any changes throughout the 12

week period.

3.5 Medication administration

Each participant received a 150ml container at monthly intervals of either unmedicated hydrogel

solution as the control medication or 12% (v/v) Allium cepa MT hydrogel solution as the

treatment. The 12% (v/v) Allium cepa MT hydrogel solution was prepared by Fusion

Homoeopathics, an independent homoeopathic medicine supplier where 18ml of Allium cepa

MT was mixed with 132ml of hydrogel and produced a 12% (v/v) Allium cepa MT hydrogel

solution. Participants were requested to apply 2ml of the provided medication topically (using

provided medicating spoons) on the targeted area twice daily for twelve weeks. No other topical

treatment was to be used by participants during this period.

3.6 Reliability and validity

The active and control medication was manufactured, packaged and randomised (using

medication codes assigned to treatment group and control groups) by Fusion Homoeopathics.

As a registered independent homoeopathic medicine supplier, Fusion Homeopathics, was able to

assure quality control of medication. Upon completion of the study, the manufacturer informed

the researcher as to which group of medications were medicated or unmedicated. The physical

evaluation of each caesarean scar was only performed by the researcher that ensured reliability.

The photographs were standardised by using consistent participant positioning, lighting, the

camera angle and setting. By ensuring standardised positioning of photographs, participants were

26

requested to lie supine on the examination bed; the camera was placed above the participant so

that the borders of the abdomen were contained within the periphery of the photograph. For

measuring purposes the Digimizer® software was used and a standard measuring apparatus was

included in the photographic field for purposes of calibration.

The POSAS (Appendix E) is a recognised, valid and reliable tool used for assessing scars.

According to the POSAS website (www.posas.org.za) the POSAS is free to use at any time as

long as it was not modified. It has been demonstrated that the POSAS is a reliable and valid

scale and provides a unidimensional measure for scar quality (Van der Wal et al., 2012). The

POSAS appears to be the most comprehensive assessment scale by taking into account the

patient‟s assessment of their own scar (Vercelli et al., 2009).

3.7 Data collection and analysis

Data was compiled and collated from all completed POSAS evaluation forms. A size comparison

(area, length and width) of the participant‟s caesarean section scar was completed using

photographs and Digimizer® software analysis. All data was collected by the researcher and

provided to Statkon for EDA (Exploratory Data Analysis). Parametric intergroup analysis

included the independent T-sample test, followed by intragroup analysis using the ANOVA

measurement. Non-parametric intergroup analysis included the Mann-Whitney U test, while

intragroup analysis involved the Friedman and the Wilcoxon signed-rank test (Van Staden,

2014).

27

CHAPTER FOUR

RESULTS

4.1 Introduction

The results obtained in the study are presented in this chapter. The data obtained during the study

was statistically analyzed with the assistance of a statistician at STATKON (Appendix F).

The aim of this study is to determine the efficacy of 12% (v/v) Allium cepa MT in a hydrogel

solution on the appearance of CS scars using the POSAS and digital photographical evidence.

Treatment started at baseline which was week 0 (W0). Both groups were supplied with either un-

medicated hydrogel or hydrogel medicated with Allium cepa 12% MT. Participants were

instructed to apply the gel to their CS scar twice a day for 12 weeks. Follow up consultations

were at week 4 (W4), week 8 (W8) and week 12 (W12). During these consultations the POSAS

(Appendix A) was completed to analyse the scar by the observer and patient separately. The

analysis also included demographic data and objective assessments with photographical

documentation.

The data captured during the study was statistically analysed with the assistance of a statistician

from STATKON using Non-parametric tests which included the Mann-Whitney U test, the

Friedman test and the Wilcoxon Signed Ranks test (van Staden, 2015). Descriptive and cross

tabulation was done for the demographic information between the groups. These non-parametric

tests were conducted as there was a lack of normality across the distribution of variables (Van

Staden, 2014).

Shapiro-Wilk Test

The Shapiro-Wilk test is a statistical test for normality of data (intra-group analysis). A p value

greater than 0.05 (p>0.05) indicated that parametric tests should be used, and a p value less than

0.05 (p<0.05) designates that there is a lack of normality, which indicates the use of non-

parametric tests (Pallant, 2007).

Mann-Whitney U test

The Mann-Whitney U test is a non-parametric test for an independent sample group that

indicated the difference between the control and treatment groups (inter-group analysis). On a

28

consistent variable, a p value < 0.05 shows statistical significant change between the groups

(Pallant, 2007).

Friedman Test

The Friedman test helps with intra-group analysis and is used to determine if there is a

statistically significant difference in severity of symptoms over different time periods, for the

control and treatment groups. The Friedman test is a non-parametric test that indicates change

over time and evaluates normality between the two groups. A p value less than 0.05 (p<0.05)

indicated statistical significant change over time (Pallant, 2007).

Wilcoxon Signed Ranks test

The Wilcoxon Signed Ranks is a non-parametric test which gives an indication of a statistically

significant difference existing between the two groups. A p value less than 0.05 (p<0.05) shows

a statistically significant difference between the two groups. However when there is a

comparison of more than one set of two points, the Bonferroni adjustment must be taken into

account (Pallant, 2007).

The Bonferroni adjustment is a post hoc test that follows the Wilcoxon Signed Ranks test where

an adjustment to the original p value is applied. The use of the Bonferroni adjustment can be

seen in this study, where there are three comparisons; W0-W4, W0-W8, W0-W12. The p value

of 0.05 is divided by 3 therefore if the p value is less than 0.02 (p<0.02) there was a statistically

significant difference (Van Staden, 2015).

4.2 Participant recruitment

Forty two female participants between the ages of 18-50 years were recruited in this study and

assessed for eligibility. As illustrated in Figure 4.1, 42 participants were randomized into a

treatment and control group: 22 participants were allocated to the control group and 20

participants to the treatment group. Two participants withdrew themselves from the study within

the first follow up of treatment: one participant gave no reason for withdrawing, while the other

participant found out she was pregnant and felt that it was unnecessary to continue as she chose

to have an elective CS. At the end of the twelve week period, 20 participants were analysed in

the control and the treatment group.

29

Figure 4.1 CONSORT flow diagram

4.3 Demographic data analysis

4.3.1 Age distribution

Female participants between the ages of 18-50 were recruited in the study. In order to assess

even distribution of ages between and within the group a cross tabulation was used.

Table 4.1 indicates that the mean age in the control group is 33.41 years of age, and treatment

group is 32.7 years of age. The standard deviation from the mean age in the control group is

4.973 years and in the treatment group it is 6.165 years. The youngest person in the control

group was 27 years old and in the treatment group she was 22 year of age. The oldest person in

the control group was 47 years old and in the treatment group she was 45 years of age. The age

distribution within and between the two sample groups were comparable.

30

Conferring to the age normality distribution statistics in Table 4.1 the p-value from Shapiro-

Wilk test for the control group was p=0.012 and for the treatment group p=0.063. This indicates

that the treatment group has a p-value greater than 0.05 showing that it has an age distribution

that is normal. However, the control group has a p-value less than 0.05 and does not have a

normal age distribution.

Table 4.1 Age distribution

Control group Treatment group

N Valid 22 20

Missing 0% 0%

Mean 33.41 32.70

Median 32.00 32.00

Std.dev 4.973 6.165

Minimum 27 22

Maximum 47 45

Shapiro-Wilk sig. 0.012 0.063

4.3.2 Number of previous CS

Participants were recruited regardless of the number of CS they had previously. A cross

tabulation was used to determine the number and percentage of previous CS that participants

have undergone.

As per Table 4.2 a majority of 23 participants (54.8%) had reported only one CS previously.

These were evenly divided across the control group (11) and the treatment group (12). The

remaining number of participants had reported two CS previously (17) and was split between the

control group (10) and the treatment group (7). Two participants (4.8%) reported to have had

three CS previously, one in the control group and the other one in the treatment group. The

numbers of previous CS are represented in Figure 4.2 (control) and Figure 4.3 (treatment) for

both groups.

31

Table 4.2 Number of previous CS

Number of previous CS 1 2 3 Total

Control group

Number of participants 11 10 1 22

Percentage 50% 45.50% 4.50% 100%

Treatment group

Number of participants 12 7 1 20

Percentage 60% 35.00% 5.00% 100%

Total

Number of participants 23 17 2 42

Percentage 54.80% 40.50% 4.80% 100%

Figure 4.2 Number of Previous CS in Control group

11

10

1

1

2

3

32

Figure 4.3 Number of CS in Treatment group

4.4 POSAS Observer Scale

The Observer scale of the POSAS (Appendix E) consists of six items (vascularity, pigmentation,

thickness, relief, pliability, surface area and overall opinion). All items are scored on a scale

ranging from 1 (“like normal skin”) to 10 (“worst scar imaginable”). The parameters were

matched to normal skin on the comparable anatomical location by the Observer.

4.4.1 Vascularity

Vascularity is the presence of vessels in scar tissue assessed by the amount of erythema. This

was tested by the amount of blood returned after blanching the scar with a piece of Plexiglas.

The vascularity of the scar was then associated towards a category (pale, purple, pink or mixed)

presented on the POSAS Observer scale.

Figure 4.4 illustrates the mean value on the POSAS Observer scale for vascularity between the

control group and the treatment group. A decrease in the mean value indicates a decrease /

improvement in vascularity. The mean value for vascularity of the control group at W0 was 4.27,

which then decreased (improved) to 3.55 at W4, and then further decreased to 2.65 at W8 and to

2.50 at W12. This represents an overall improvement of 1.77 (41.45%). The mean value for

vascularity of the treatment group at W0 was 3.90, which then reduced (improved) to 3.50 at

12

7

1

1

2

3

33

W4, and then further decreased to 2.55 at W8 and to 2.15 at W12. This represents an overall

improvement of 1.75 (44.87%).

Figure 4.4 POSAS Observer scale – Vascularity

Intra-group analysis

As per Table 4.3 the Friedman test illustrates that there is a statistically significant difference for

the control group (p=0.000) and the treatment group (p=0.000) over time regarding vascularity

of the scar.

Table 4.3 Friedman test – Vascularity

Friedman test N Chi Square Df Asymp Sig.

Control group 20 29.975 3 0.000

Treatment group 20 36.936 3 0.000

As seen in Table 4.4 there was a statistical significance for the control group between W0-W4

(p=0.007), W0-W8 (p=0.001) and between W0-W12 (p=0.001). However for the treatment

group there was no statistically significant difference between W0-W4 (p=0.174). There was

however a statistically significant difference between W0-W8 (p=0.000) and W0-W12 (p=0.000)

in the treatment group.

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

W0 W4 W8 W12

Mea

n v

alue

POSAS Observer Scale - Vascularity

Control group

Treatment group

34

Table 4. 4 Wilcoxon Signed Ranks test – Vascularity

Wilcoxon Signed Ranks Test Vasc.W0-W4 Vasc.W0-W8 Vasc.W0-W12

Control group Asymp. Sig 0.007 0.001 0.001

Treatment group 0.174 0.000 0.000

Inter-group analysis

When comparing the results of each group (Table 4.5) by way of inter-group analysis (Mann-

Whitney U test), there was no significant difference found between the control and the treatment

group at W0 (p=0.858); W4 (p=0.641); W8 (p=0.900) and W12 (p=0.498). The two groups

showed no statistical difference at W0 which made them comparable to each other; however the

statistical insignificance at W12 also demonstrates comparability of results by the end of the

study.

Table 4.5 Mann-Whitney U test – Vascularity

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.858 0.641 0.9 0.498

4.4.2 Pigmentation

Pigmentation is the brownish discolouration of the scar due to pigment (melanin). Pigmentation

was evaluated by applying Plexiglas to the skin with moderate pressure to eliminate the effect of

vascularity.

Figure 4.5 illustrates the mean value on the POSAS Observer scale for pigmentation between

the control group and the treatment group. The mean value for pigmentation of the control group

improved by 1.64 (39.61%) over the course of the 12 weeks from 4.14 to 2.50.However the

treatment group improved by 1.80 (45%) over the course of the 12 weeks from 4.00 to 2.20.

35

Figure 4.5 POSAS Observer scale – Pigmentation

Intra-group analysis

As per Table 4.6 the Friedman test illustrates that there is a statistically significant difference for

the control group (p=0.000) and the treatment group (p=0.000) over time regarding pigmentation

of the scar.

Table 4. 6 Friedman test – Pigmentation

Friedman test N Chi Square Df Asymp Sig.

Control group 20 26.097 3 0.000

Treatment group 20 31.091 3 0.000

According to Table 4.7 there is a statistical significance for the control group between W0-W4

(p=0.007), W0-W8 (p=0.002) and between W0-W12 (p=0.001). However for the treatment

group there was no statistical significant difference between W0-W4 (p=0.088). There was

however a statistically significant difference between W0-W8 (p=0.001) and W0-W12 (p=0.000)

relevant to the treatment group.

Table 4.7 Wilcoxon Signed Ranks test – Pigmentation

Wilcoxon Signed Ranks Pig. W0-W4 Pig. W0-W8 Pig. W0-W12

Control group Asymp. Sig 0.007 0.002 0.001

Treatment group 0.088 0.001 0.000

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

W0 W4 W8 W12

Mea

n v

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POSAS Observer scale - Pigmentation

Control group

Treatment group

36

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was no significant difference (Table 4.8) found between the control and the treatment

group at W0 (p=0.54); W4 (p=0.353); W8 (p=0.331) and W12 (p=0.682). The two groups

showed no statistical difference at W0 which made them comparable to each other; however the

statistical insignificance at W12 also demonstrates comparability of results by the end of the

study.

Table 4. 8 Mann-Whitney U test – Pigmentation

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.54 0.353 0.331 0.682

4.4.3 Thickness

Thickness of the scar is determined as the average distance between the subcutical-border and

the epidermal surface of the scar.

Figure 4.6 illustrates the mean value on the POSAS Observer scale for scar thickness between

the control group and the treatment group. The mean value for thickness of the control group at

W0 was 4.36, which then decreased (improved) to 3.75 at W4, and then further decreased to 3.30

at W8 and to 3.20 at W12. This indicates an overall improvement of 1.16 (26.60%). The mean

value for thickness of the treatment group at W0 was 4.15, which then reduced (improved) to

3.60 at W4, and then further decreased to 2.85 at W8 and to 2.45 at W12, representing an overall

improvement of 1.70 (40.96%).

37

Figure 4.6 POSAS Observer scale – Thickness

Intra-group analysis

As per Table 4.9 the Friedman test illustrates that there is a statistically significant difference for

the control group (p=0.000) and the treatment group (p=0.000) over time regarding thickness of

the scar.

Table 4. 9 Friedman test – Thickness

Friedman test N Chi Square df Asymp Sig.

Control group 20 24.239 3 0.000

Treatment group 20 41.408 3 0.000

According to Table 4.10 there is a statistically significance for the control group between W0-

W4 (p=0.006), W0-W8 (p=0.001) and between W0-W12 (p=0.001). However for the treatment

group there was no statistically significant difference between W0-W4 (p=0.026). There was

however a statistically significant difference between W0-W8 (p=0.000) and W0-W12 (p=0.000)

relevant to the treatment group.

Table 4.10 Wilcoxon Signed Ranks test – Thickness

Wilcoxon Signed Ranks Thick.W0-W4 Thick.W0-W8 Thick.W12

Control group Asymp. Sig 0.006 0.001 0.001

Treatment group 0.026 0.000 0.000

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

W0 W4 W8 W12

Mea

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POSAS Observer scale - Thickness

Control group

Treatment group

38

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there were no significant differences (Table 4.11) found between the control and the

treatment group at W0 (p=0.599); W4 (p=0.544); W8 (p=0.615) and W12 (p=0.779). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however the statistical insignificance at W12 also demonstrates comparability of results by the

end of the study.

Table 4.11 Mann-Whitney U test – Thickness

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.599 0.544 0.615 0.779

4.4.4 Relief

Relief signifies the extent to which surface irregularities are present, compared to adjacent skin.

The change in the POSAS Observer scale for Relief from W0-W12 all decreased within the

control and treatment group (Figure 4.7). At W0 the mean value for the control group was 4.32.

The mean value decreased in W4 to 3.75 and 3.15 in W8. By W12 the mean value dropped by

1.32 to 3, representing an overall improvement of 30.55%. At W0 the mean value for the

treatment group was 3.95. The mean value decreased in W4 to 3.65 and 2.90 in W8. By W12 the

mean value dropped by 1.65 to 2.3, representing an overall improvement of 41.77%.

Figure 4. 7 POSAS Observer scale – Relief

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

W0 W4 W8 W12

Mea

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POSAS Observer scale - Relief

Control group

Treatment group

39

Intra-group analysis

The Friedman test results in Table 4.12 illustrates that there is a statistically significant

difference for the control group (p=0.000) and the treatment group (p=0.000) over time

regarding relief of the scar.

Table 4.12 Friedman test – Relief

Friedman test N Chi Square df Asymp Sig.

Control group 20 32.980 3 0.000

Treatment group 20 39.735 3 0.000

According to Table 4.13 there is a statistical significance for the control group between W0-W4

(p=0.003), W0-W8 (p=0.000) and between W0-W12 (p=0.000) as seen in the results of the

Wilcoxon Signed Ranks test. However for the treatment group there was no statistically

significant difference between W0-W4 (p=0.083). There was however a statistically significant

difference between W0-W8 (p=0.001) and W0-W12 (p=0.000) for the treatment group.

Table 4.12 Wilcoxon Signed Ranks test– Relief

Wilcoxon Signed Ranks Relief W0-W4 Relief W0-W8 Relief W0-W12

Control group Asymp. Sig 0.003 0.000 0.000

Treatment group 0.083 0.001 0.000

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was no significant difference (Table 4.14) found between the control and the

treatment group at W0 (p=0.718); W4 (p=0.560); W8 (p=0.656) and W12 (p=0.449). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however the statistical insignificance at W12 also demonstrates comparability of results by the

end of the study.

Table 4.13 The Mann-Whitney U test – Relief

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.718 0.560 0.656 0.449

40

4.4.5 Pliability

Pliability refers to the suppleness of the scar, tested by wrinkling the scar between the thumb and

index finger.

Figure 4.8 illustrates the mean value on the POSAS Observer scale for pliability between the

control group and the treatment group. The mean value for pliability of the control group

improved by 1.50 (33.70%) over the course of the 12 weeks from 4.45 to 2.95 (Figure 4.8).

However the treatment group improved by 2.2 (48.35%) over the course of the 12 weeks from

4.55 to 2.15 (Figure 4.8).

Figure 4.8 POSAS Observer scale – Pliability

Intra-group analysis

As per Table 4.15 the Friedman test illustrates that there is a statistically significant difference

for the control group (p=0.000) and the treatment group (p=0.000) over time regarding pliability

of the scar.

Table 4.14 Friedman test – Pliability

Friedman test N Chi Square Df Asymp Sig.

Control group 20 33.090 3 0.000

Treatment group 20 41.180 3 0.000

According to Table 4.16 there is a statistical significance for the control group between W0-W4

(p=0.003), W0-W8 (p=0.001) and between W0-W12 (p=0.000).

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

W0 W4 W8 W12

Mea

n v

alue

POSAS Observer scale - Pliability

Control group

Treatment group

41

There was a statistically significant difference for the treatment group between W0-W4

(p=0.010); W0-W8 (p=0.001) and W0-W12 (p=0.000).

Table 4.15 Wilcoxon Signed Ranks test – Pliability

Wilcoxon Signed Ranks Plia.W0-W4 Plia. W0-W8 Plia. W0-W12

Control group Asymp. Sig 0.003 0.001 0.000

Treatment group 0.010 0.001 0.000

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was no significant difference (Table 4.17) found between the control and the

treatment group at W0 (p=0.452); W4 (p=0.400); W8 (p=0.561) and W12 (p=0.575). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however the statistical insignificance at W12 also demonstrates comparability of results by the

end of the study.

Table 4.16 Mann-Whitney U test – Pliability

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.452 0.400 0.561 0.575

4.4.6 Surface area

Surface area of the scar is measured in relation to the original wound area.

Figure 4.9 illustrates the mean value on the POSAS Observer scale for surface area between the

control group and the treatment group. The mean value for surface area of the control group at

W0 was 4.23, which then decreased (improved) to 3.55 at W4 and then further decreased to 3.20

at W8 and to 3.05 at W12, representing an overall improvement of 1.18 (27.9%). The mean

value for surface area of the treatment group at W0 was 4.80, which then reduced (improved) to

4.30 at W4, and then further decreased to 3.20 at W8 and to 2.80 at W12. This represents an

overall improvement of 2 (46.511%).

42

Figure 4.9 POSAS Observer scale – Surface area

Intra-group analysis

As per Table 4.18 the Friedman test illustrates that there is a statistical significant difference for

the control group (p=0.000) and the treatment group (p=0.000) over time regarding surface area

of the scar.

Table 4.17 Friedman test – Surface area

Friedman test N Chi Square df Asymp Sig.

Control group 20 18.714 3 0.000

Treatment group 20 38.098 3 0.000

According to Table 4.19 there is a statistical significance for the control group between W0-W4

(p=0.009), W0-W8 (p=0.005) and between W0-W12 (p=0.002). Conversely for the treatment

group there was no statistically significant difference between W0-W4 (p=0.032). There was

however a statistically significant difference between W0-W8 (p=0.001) and W0-W12 (p=0.000)

relevant to the treatment group.

Table 4.18 Wilcoxon Signed Ranks test – Surface area

Wilcoxon Signed Ranks AreaW0-W4 AreaW0-W8 AreaW0-W12

Control group Asymp. Sig 0.009 0.005 0.002

Treatment group 0.032 0.001 0.000

0

1

2

3

4

5

6

W0 W4 W8 W12

Mea

n v

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POSAS Observer scale - Surface area

Control group

Treatment group

43

Inter-group analysis

When comparing the results of each group (Table 4.20) by way of inter-group analysis (Mann-

Whitney U test), there was no significant difference found between the control and the treatment

group at W0 (p=0.323); W4 (p=0.217); W8 (p=0.716) and W12 (p=0.945). The two groups

showed no statistical difference at W0 which made them comparable to each other; however the

statistical insignificance at W12 also demonstrates comparability of results by the end of the

study.

Table 4.19 Mann-Whitney U test – Surface area

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.323 0.217 0.716 0.945

4.4.7 Overall opinion of Observer

Figure 4.10 illustrates the mean value on the POSAS Observer scale for the overall opinion of

the Observer between the control group and the treatment group. The mean value for the overall

opinion of the control group improved by 1.34 (29.19%) over the course of the 12 weeks from

4.59 to 3.25 (Figure 4.10). The treatment group improved by 1.65 (37.08%) over the course of

the 12 weeks from 4.45 to 2.80 (Figure 4.10).

Figure 4.10 POSAS Observer scale – Overall opinion

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

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W0 W4 W8 W12

Mea

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POSAS Observer scale - Overall opinion

Control group

Treatment group

44

Intra-group analysis

As per Table 4.21 the Friedman test illustrates that there is a statistically significant difference

for the control group (p=0.000) and the treatment group (p=0.000) over time regarding the

overall opinion of the scar.

Table 4.20 Friedman test – Overall opinion

Friedman test N Chi Square df Asymp Sig.

Control group 20 36.737 3 0.000

Treatment group 20 44.018 3 0.000

According to Table 4.22 there is a statistical significance for the control group between W0-W4

(p=0.002), W0-W8 (p=0.000) and between W0-W12 (p=0.000). There was a statistically

significant difference for the treatment group between W0-W4 (p=0.001); W0-W8 (p=0.001) and

W0-W12 (p=0.000). This shows that a significant change occurred over time, for both groups

(p<0.02), throughout the 12 week period.

Table 4.21 Wilcoxon Signed Ranks test – Overall opinion

Wilcoxon Signed Ranks Opin. W0-W4 Opin. W0-W8 Opin. W0-W12

Control group Asymp. Sig 0.002 0.000 0.000

Treatment group 0.001 0.001 0.000

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was no significant difference (Table 4.23) found between the control and the

treatment group at W0 (p=0.634); W4 (p=0.334); W8 (p=0.879) and W12 (p=0.397). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however the statistical insignificance at W12 also demonstrates comparability of results by the

end of the study.

Table 4. 22 Mann-Whitney U test – Overall opinion

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.634 0.334 0.879 0.397

45

4.5 POSAS Patient scale

The Patient scale of the POSAS (Appendix E) consists of six questions regarding the scar (pain,

itching, colour, stiffness, thickness and regularity). All items are scored on a scale ranging from

1 (“no, not at all”) to 10 (“yes, very much”) by the patient. All parameters were compared to

normal skin on the comparable anatomical location.

4.5.1 Pain

Figure 4.11 illustrates the mean value on the POSAS Patient scale for pain between the control

group and the treatment group. The mean value for pain of the control group at W0 was 2.40.

This value increased to 2.45 at W4, then decreased (improved) to 2.40 at W8, and increased at

W12 to 2.45. The mean value for pain of the treatment group at W0 was 1.45, which then

increased slightly to 1.85 at W4, and then decreased to 1.50 at W8. IT remained steady on 1.50 at

W12. No improvements were observed for the control group and treatment group with regards to

scar pain.

Figure 4.11 illustrates that after the gel was applied between W0-W4 there was an increase in

pain for both groups. The treatment group‟s mean value evened out after W4 and stayed steady

thereafter. The control group on the other hand, had a slight increase and slight decrease of pain

throughout the entire 12 week period.

Figure 4.11 POSAS Patient scale – Pain

0

0.5

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1.5

2

2.5

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W0 W4 W8 W12

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POSAS Patient scale - Pain

Control group

Treatment group

46

Intra-group analysis

As per Table 4.24 there was no statistically significant difference for the control group

(p=0.945) and the treatment group (p=0.733) over time regarding the pain of the scar.

Table 4.23 Friedman test – Pain

Friedman test N Chi Square Df Asymp Sig.

Control group 20 0.375 3 0.945

Treatment group 20 1.286 3 0.733

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was a statistically significant difference (Table 4.25) found between the control and

the treatment group at W0 (p=0.037). The two groups showed a statistically significant

difference at W0 which made them non-comparable to each other to start off with. However no

statistical significance was observed at W4 (p=0.085); W8 (p=0.266) and at W12 (p=0.116).

Table 4.24 Mann-Whitney U test – Pain

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.037 0.085 0.266 0.116

4.5.2 Itching

The change in the POSAS Patient scale for itching from W0-W12 all decreased within the

control and treatment group (Figure 4.12). At W0 the mean value for the control group was

3.60. The mean value decreased in W4 to 2.95, and to 2.85 in W8. By W12 the mean value

increased slightly to 2.90, however there was still an overall improvement of 0.7 (19.44%). At

W0 the mean value for the treatment group was 2.25. The mean value increased in W4 to 2.30

and then decreased (improved) to 2.05 in W8. By W12 the mean value dropped to 1.85,

representing an overall improvement of 0.4 (17.77%).

47

Figure 4.12 POSAS Patient scale – Itching

Intra-group analysis

As per Table 4.26 the Friedman test illustrates that there is no statistical significant difference

for the control group (p=0.073) and the treatment group (p=0.452) over time regarding itchiness

of the scar.

Table 4. 25 Friedman test – Itching

Friedman test N Chi Square Df Asymp Sig.

Control group 20 7.010 3 0.073

Treatment group 20 2.630 3 0.452

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test) there was no statistically significant difference found between the control and the treatment

group at W0 (p=0.314); W4 (p=0.328); W8 (p=0.533) and W12 (p=0.218). The two groups

showed no statistical difference at W0 which made them comparable to each other; however the

statistical insignificance at W12 also demonstrates comparability of results by the end of the

study (Table 4.27).

Table 4. 26 Mann-Whitney U test – Itching

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.314 0.328 0.533 0.218

0

0.5

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1.5

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3.5

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W0 W4 W8 W12

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POSAS Patient scale - Itching

Control group

Treatment group

48

4.5.3 Colour

Figure 4.13 illustrates the mean value on the POSAS Patient scale for the colour of the scar

between the control group and the treatment group. The mean value for colour of the control

group improved by 0.95 (18.73%) over the course of the 12 weeks from 5.23 to 4.25. However,

the treatment group improved significantly by 2.95 (45.38%) over the course of the 12 weeks

from 6.50 to 3.55 (Figure 4.13).

Figure 4.13 POSAS Patient scale – Colour

Intra-group analysis

As per Table 4.28 the Friedman test illustrates that there is a statistically significant difference

for the treatment group (p=0.000) only. The control group showed no statistical significance

(p=0.205).

Table 4.27 Friedman test – Colour

Friedman test N Chi Square df Asymp Sig.

Control group 20 4.579 3 0.205

Treatment group 20 31.817 3 0.000

According to Table 4.29 there is no statistically significant difference for the control group

between W0-W4 (p=0.131), W0-W8 (p=0.075) and between W0-W12 (p=0.091). However for

the treatment group there was a statistically significant difference between W0-W4 (p=0.013);

W0-W8 (p=0.002) and W0-W12 (p=0.000).

0

1

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W0 W4 W8 W12

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POSAS Patient scale - Colour

Control group

Treatment group

49

Table 4.28 Wilcoxon Signed Ranks test – Colour

Wilcoxon Signed Ranks Colr.W0-W4 Colr.W0-W8 Colr.W0-W12

Control group Asymp. Sig 0.131 0.075 0.091

Treatment group 0.013 0.002 0.000

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was no significant difference (Table 4.30) found between the control and the

treatment group at W0 (p=0.157); W4 (p=0.279); W8 (p=0.870) and W12 (p=0.302). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however the statistical insignificance at W12 also demonstrates comparability of results by the

end of the study.

Table 4.29 Mann-Whitney U test – Colour

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.157 0.279 0.870 0.302

4.5.4 Stiffness

Figure 4.14 illustrates the mean value on the POSAS Patient scale for stiffness between the

control group and the treatment group. At W0 the mean value for the control group was 5.55.

The mean value decreased in W4 to 4.95, and to 4.50 in W8. By W12 the mean value slightly

increased to 4.55, however still representing an overall improvement of 1 (18.01%). At W0 the

mean value for the treatment group was 5.85. The mean value decreased in W4 to 4.15 and to

3.75 in W8. By W12 the mean value dropped (improved) by 2.60, representing an overall

significant improvement of 3.25 (55.55%) for the treatment group.

50

Figure 4.14 POSAS Patient scale – Stiffness

Intra-group analysis

As per Table 4.31 the Friedman test illustrates that there is a statistically significant difference

for the control group (p=0.011) and the treatment group (p=0.000) over time regarding stiffness

of the scar.

Table 4.30 Friedman test – Stiffness

Friedman test N Chi Square df Asymp Sig.

Control group 20 11.197 3 0.011

Treatment group 20 30.054 3 0.000

According to Table 4.32 there is a statistical significance for the control group between W0-W4

(p=0.042), W0-W8 (p=0.014) and between W0-W12 (p=0.011). There was a statistically

significant difference for the treatment group between W0-W4 (p=0.012), W0-W8 (p=0.010) and

W0-W12 (p=0.000). This shows that a change occurred over time for both groups (p<0.02)

throughout the 12 week period.

Table 4.31 Wilcoxon Signed Ranks test – Stiffness

Wilcoxon Signed Ranks Stiff.W0-W4 Stiff.W0-W8 Stiff.W0-W12

Control group Asymp. Sig 0.042 0.014 0.011

Treatment group 0.012 0.010 0.000

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POSAS Patient scale - Stiffness

Control group

Treatment group

51

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was no significant difference (Table 4.33) found between the control and the

treatment group at W0 (p=0.601); W4 (p=0.268) and at W8 (p=0.184). There was however a

statistical significance at W12 (p=0.008). The two groups showed no statistical difference at W0

which made them comparable to each other; however the statistically significant results at W12

demonstrates incomparability between the control (18.01% improvement) and the treatment

(55.55% improvement) group at the end of the study.

Table 4.32 Mann-Whitney U test – Stiffness

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.601 0.268 0.184 0.008

4.5.5 Thickness

Figure 4.15 illustrates the mean value on the POSAS Patient scale for scar thickness between the

control group and the treatment group. The mean value for thickness of the control group

improved by 2.94 (47.88%) over the course of the 12 weeks from 6.14 to 3.20. However, the

treatment group improved by 4.05 (60%) over the course of the 12 weeks from 6.75 to 2.70

(Figure 4.15).

Figure 4.15 POSAS Patient scale – Thickness

0

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4

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6

7

8

W0 W4 W8 W12

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POSAS Patient scale - Thickness

Control group

Treatment group

52

Intra-group analysis

As per Table 4.34 the Friedman test illustrates that there is a statistically significant difference

for the control group (p=0.001) and the treatment group (p=0.000) over time regarding thickness

of the scar.

Table 4.33 Friedman test – thickness

Friedman test N Chi Square df Asymp Sig.

Control group 20 16.921 3 0.001

Treatment group 20 33.468 3 0.000

According to Table 4.35 there is a statistical significance for the control group between W0-W4

(p=0.012), W0-W8 (p=0.002) and between W0-W12 (p=0.007). There was a statistically

significant difference for the treatment group between W0-W4 (p=0.001), W0-W8 (p=0.003) and

between W0-W12 (p=0.000). This shows that a significant change occurred over time, for both

groups, throughout the 12 week period.

Table 4.34 Wilcoxon Signed Ranks test – Thickness

Wilcoxon Signed Ranks Thick.W0-W4 Thick.W0-W8 Thick.W0-W12

Control group Asymp. Sig 0.012 0.002 0.007

Treatment group 0.001 0.003 0.000

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test). There was no significant difference (Table 4.36) found between the control and the

treatment group at W0 (p=0.445); W4 (p=0.405); W8 (p=0.452) and W12 (p=0.008). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however the statistically significant results at W12 demonstrates incomparability between the

control (47.8% improvement) and the treatment (60% improvement) group at the end of the

study.

Table 4.35 Mann- Whitney U test – Thickness

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.445 0.405 0.452 0.008

53

4.5.6 Irregularity

Figure 4.16 illustrates the mean value on the POSAS Patient scale for scar regularity between

the control group and the treatment group. The mean value for regularity of the control group

improved by 1.55 (25.61%) over the course of the 12 weeks from 6.05 to 4.50 (Figure 4.16).

However the treatment group improved by 3.35 (51.53%) over the course of the 12 weeks from

6.50 to 3.15 (Figure 4.16).

Figure 4.16 POSAS Patient scale – Irregularity

Intra-group analysis

As per Table 4.37 the Friedman test illustrates that there is a statistical significant difference for

the control group (p=0.000) and the treatment group (p=0.000) over time regarding irregularities

of the scar.

Table 4.36 Friedman test – Irregularity

Friedman test N Chi Square df Asymp Sig.

Control group 20 21.152 3 0.000

Treatment group 20 28.724 3 0.000

According to Table 4.38 there was no statistical significance for the control group between W0-

W4 (p=0.028), however there was a statistically significant difference between W0-W8

(p=0.002) and W0-W12 (p=0.001). The treatment group illustrated a statistically significant

difference between W0-W4 (p=0.005); W0-W8 (p=0.003) and W0-W12 (p=0.000).

0

1

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4

5

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POSAS Patient scale - Irregularity

Control group

Treatment group

54

Table 4.37 Wilcoxon Signed Ranks test – Irregularity

Wilcoxon Signed Ranks Test Reg.W0-W4 Reg.W0-W8 Reg.W0-W12

Control group Asymp. Sig 0.028 0.002 0.001

Treatment group 0.005 0.003 0.000

Inter-group analysis

When comparing the results of each group (Table 4.39) by way of inter-group analysis (Mann-

Whitney U test), there was no significant difference found between the control and the treatment

group at W0 (p=0.575); W4 (p=0.604); W8 (p=0.913) and W12 (p=0.080). The two groups

showed no statistical difference at W0 which made them comparable to each other; however the

statistical insignificance at W12 also demonstrates comparability of results by the end of the

study.

Table 4.38 Mann-Whitney U test – Irregularities

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.575 0.604 0.913 0.080

4.5.7 Overall opinion

Figure 4.17 illustrates the mean value on the POSAS Patient scale for overall opinion between

the control group and the treatment group. At W0 the mean value for the control group was 5.95.

The mean value decreased in W4 to 4.85 and 4.50 in W8. By W12 the mean stayed at 4.50,

representing an overall improvement of 1.45 (24.36%). At W0 the mean value for the treatment

group was 7.05. The mean value decreased in W4 to 5.60 and 4.10 in W8. By W12 the mean

value dropped (improved) to 3.20, representing an overall significant improvement of 3.85

(54.61%).

55

Figure 4.17 POSAS Patient scale – Overall opinion

Intra-group analysis

As per Table 4.40 the Friedman test illustrates that there is a statistically significant difference

for the control group (p=0.000) and the treatment group (p=0.000) over time regarding the

participant‟s overall opinion of their scar.

Table 4.39 Friedman test – Overall opinion

Friedman test N Chi Square df Asymp Sig.

Control group 20 24.902 3 0.000

Treatment group 20 45.568 3 0.000

According to Table 4.41 there is a statistical significance for the control group between W0-W4

(p=0.004); W0-W8 (p=0.001) and between W0-W12 (p=0.001). There was also a statistically

significant difference for the treatment group between W0-W4 (p=0.004); W0-W8 (p=0.000) and

W0-W12 (p=0.000).

Table 4.40 Wilcoxon Signed Ranks test – Overall opinion

Wilcoxon Signed Ranks Test Opin.W0-W4 Opin.W0-W8 Opin.W0-W12

Control group Asymp. Sig 0.004 0.001 0.001

Treatment group 0.004 0.000 0.000

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1

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3

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6

7

8

W0 W4 W8 W12

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POSAS Patient scale - Overall opinion

Control group

Treatment group

56

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was no significant difference (Table 4.42) found between the control and the

treatment group at W0 (p=0.168); W4 (p=0.292); W8 (p=0.495) and W12 (p=0.036). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however the statistically significant results at W12 demonstrates incomparability between the

control (24.36% improvement) and the treatment (54.61% improvement) group at the end of the

study.

Table 4. 41 Mann-Whitney U test – Overall opinion

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.168 0.292 0.495 0.036

4.6 Digimizer®

4.6.1 Surface area of scar

Figure 4.18 illustrates the mean value on the Digimizer® programme for surface area of the scar

between the control group and the treatment group. The mean value for surface area of the

control group at W0 was 4.227, which then decreased (improved) to 3.274 at W4, and then

further decreased to 2.644 at W8 and to 2.331 at W12. This represents an overall improvement of

1.896 (44.85%). The mean value for surface area of the treatment group at W0 was 5.667, which

then slightly increased to 5.818 at W4 and then further decreased to 3.633 at W8 and to 2.922 at

W12, representing an overall improvement of 2.745 (48.43%).

57

Figure 4.18 Digimizer® - Surface area

Intra-group analysis

As per Table 4.43 the Friedman test illustrates that there is a statistically significant difference

for the control group (p=0.00) and the treatment group (p=0.00) over time regarding surface area

of the scar.

Table 4.42 Friedman test – Surface area

Friedman test N Chi Square Df Asymp Sig.

Control group 20 29.040 3 0.000

Treatment group 20 39.420 3 0.000

According to Table 4.44 there is a statistical significance for the control group between W0-W4

(p=0.012), W0-W8 (p=0.000) and between W0-W12 (p=0.000). However for the treatment

group there was no statistical significant difference between W0-W4 (p=0.025). There was

however a statistically significant difference between W0-W8 (p=0.000) and W0-W12 (p=0.000)

relevant to the treatment group.

Table 4.43 Wilcoxon Signed Ranks test – Surface area

Wilcoxon Signed Ranks Sur W0-W4 Sur W0-W8 Sur W0-W12

Control group Asymp. Sig 0.012 0.000 0.000

Treatment group 0.025 0.000 0.000

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1

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Digimizer - Surface area

Control group

Treatment group

58

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was no significant difference (Table 4.45) found between the control and the

treatment group at W0 (p=0.257); W4 (p=0.402); W8 (p=0.185) and W12 (p=0.229). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however the statistical insignificance at W12 also demonstrates comparability of results by the

end of the study.

Table 4.44 Mann-Whitney U test – Surface area

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.257 0.402 0.185 0.229

4.6.2 Length

Figure 4.19 illustrates the mean value on the Digimizer® programme for length of the scar

between the control group and the treatment group. The mean value for length of the scar in the

control group at W0 was 11.875cm. This decreased (improved) to 10.82cm at W4 and then

further decreased to 10.253cm at W8, and to 9.833cm at W12, representing an overall

improvement of 2.042cm (17.19%). The mean value for length of the scar in the treatment group

at W0 was 13.622cm, which then decreased (improved) to 13.329cm at W4, to 12.319cm at W8,

and to 12.153cm at W12, representing an overall improvement of 1.469cm (10.78%).

Figure 4.19 Digimizer®

- Length

0

2

4

6

8

10

12

14

16

W0 W4 W8 W12

Mea

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(cm

)

Digimizer - Length

Control group

Treatment group

59

Intra-group analysis

As per Table 4.46 the Friedman test illustrates that there was a statistically significant difference

for the control group (p=0.023) and the treatment group (p=0.006) over time regarding length of

the scar.

Table 4.45 Friedman test – Length

Friedman test N Chi Square Df Asymp Sig.

Control group 20 9.540 3 0.023

Treatment group 20 12.540 3 0.006

According to Table 4.47 there is no statistically significant difference for the control group

between W0-W4 (p=0.232). There was however a statistical significance for the control group

between W0-W8 (p=0.004) and between W0-W12 (p=0.008). There was also no statistical

significance for the treatment group between W0-W4 (p=0.086). There was a statistically

significant difference between W0-W8 (p=0.006) and W0-W12 (p=0.004) relevant to the

treatment group.

Table 4.46 Wilcoxon Signed Ranks test – Length

Wilcoxon Signed Ranks Len.W0-W4 Len.W0-W8 Len.W0-W12

Control group Asymp. Sig 0.232 0.004 0.008

Treatment group 0.086 0.006 0.004

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test). There was no significant difference (Table 4.48) found between the control and the

treatment group at W0 (p=0.279); W4 (p=0.245); W8 (p=0.123) and W12 (p=0.256). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however they ended incomparable at W12.

Table 4.47 Mann-Whitney U test – Length

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.279 0.245 0.123 0.256

60

4.6.3 Width

Figure 4.20 illustrates the mean value on the Digimizer® programme for width of the scar

between the control group and the treatment group. The mean value for width of the scar for the

control group at W0 was 2.08. This increased slightly to 2.385 at W4, and then decreased

(improved) to 2.063 at W8, followed by another slight increase of 2.19 at W12. There was no

improvement for scar width in the control group. The mean value for width of the treatment

group at W0 was 3.474, which then decreased (improved) to 3.139 at W4, and then further

decreased to 2.602 at W8. There was however a slight increase of 2.863 at W12, representing an

overall improvement of 0.611 (17.587%).

Figure 4.20 Digimizer®

- Width

Intra-group analysis

As per Table 4.49 the Friedman test illustrates that there is a statistically significant difference

for the control group (p=0.019) over time regarding width of the scar. There was no statistical

significance for the treatment group (p=0.115).

Table 4.48 Friedman test – Width

Friedman test N Chi Square Df Asymp Sig.

Control group 20 9.960 3 0.019

Treatment group 20 5.940 3 0.115

According to Table 4.50 there was no statistical significance for the control group between W0-

W4 (p=0.681), W0-W8 (p=0.023) and between W0-W12 (p=0.037).

0

0.5

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1.5

2

2.5

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3.5

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W0 W4 W8 W12

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Digimizer - Width

Control group

Treatment group

61

However there was no statistically significance for the treatment group between W0-W4

(p=0.167) and between W0-W12 (p=0.263), but a statistically significant difference was

observed between and W0-W04 (p=0.008) relevant to the treatment group.

Table 4.49 Wilcoxon Signed Ranks test – Width

Wilcoxon Signed Ranks Width W0-W4 Width W0-W8 Width W0-W12

Control group Asymp. Sig 0.681 0.023 0.037

Treatment group 0.167 0.008 0.263

Inter-group analysis

When comparing the results of each group by way of inter-group analysis (Mann-Whitney U

test), there was no significant difference found (Table 4.51) between the control and the

treatment group at W0 (p=0.099); W4 (p=0.449); W8 (p=0.279) and W12 (p=0.168). The two

groups showed no statistical difference at W0 which made them comparable to each other;

however the statistical insignificance at W12 also demonstrates comparability of results by the

end of the study.

Table 4.50 Mann-Whitney U test – Width

Mann-Whitney U test W0 W4 W8 W12

Asym-sig. (2-tailed) 0.099 0.449 0.279 0.168

62

CHAPTER FIVE

DISCUSSION

5.1 Introduction

This chapter is used to discuss the results obtained from chapter four.

Non-parametric analyses made use of the Friedman test, post hoc-Wilcoxon signed ranks test

and the Mann Whitney U test. Non-parametric testing tools are most accurate in larger sample

sizes, but may indicate more relatively accurate p-values in smaller sample groups compared to

parametric testing. The Wilcoxon signed ranks test made use of Bonferonni adjustments as a

post-test to determine the specific time frame in the study in which changes occurred given that

they reflected statistical significance in the Friedman test. The final sample size was 40 female

participants and it was observed by the statistician of this study that the sample sizes may have

been too small for analysis of variance in terms of parametric analyses, but was not too small to

facilitate non-parametric analyses (Van Staden, 2014).

5.2 Demographic data discussions

5.2.1 Age distribution

The study was open to women between the ages of 18 – 50 years; this allowed a wider range of

women with CS‟s in the surrounding local community to participate. The approximate mean age

of participants that partook in this study in the control group (33.41) and treatment group (32.70)

was 33 years old. Statistically the control group had a p-value less than 0.05 and does not have

normal distribution of age within the group (p=0.012). Furthermore the p-value for the treatment

group is greater than 0.05 and the age distribution is normal within the group (p=0.063). The lack

of a matching up technique at the beginning of the study may have caused the control group to

have presented with an age distribution that is not even. Future studies might consider matching

participants according to age in each group.

5.2.2 Number of previous CS

Participants were recruited regardless of the number of previous CS they have had. 4.5% of

participants in the control group and 5% of participants in the treatment group had three CS

previously. Furthermore, 45.5% of participants in the control group and 35% of the treatment

group had two CS previously. 50% of participants in the control group and 60% of participants

63

in the treatment group had one CS previously. This indicates that majority of participants in this

study have only undergone one surgical procedure.

5.3 POSAS Observer scale

The POSAS Observer scale consists of six items (vascularity, pigmentation, relief, pliability,

thickness, surface area and overall opinion) that are evaluated to assess a scar by the researcher /

observer. Depending on the degree of the scar, the researcher/observer gave a score between 1

(“like normal skin) and 10 (“worst scar imaginable”) throughout the 12 week period (W0-W12).

The Friedman test illustrated that there was a statistically significant change for both groups

regarding every criteria of the POSAS Observer scale. This confirms that there was an

improvement or change of symptoms over time regarding all parameters of the scar conferring to

the observer.

5.3.1 Vascularity, pigmentation, thickness, relief and surface area

According to the Wilcoxon Signed Ranks test the following parameters: vascularity,

pigmentation, thickness, relief and surface area of the scar, obtained similar significance relevant

to appearance and change in scar healing. A statistical significance was obtained for the control

group between every time frame throughout the twelve weeks (W0-W4, W0-W8 and W0-W12).

However the treatment group had no statistically significant results relevant to these parameters

at the beginning of the study (W0-W4) and started showing statically significant results between

W0-W8 and W0-W12 only.

A study showed that in the majority of subjects the benefits of Allium cepa are only fully defined

from eight weeks of application and onwards (Draelos, 2008). Another possible explanation

could be that inflammation has been recognized as an early participant in wound healing,

therefore parameters like vascularity, thickness (swelling), relief and surface area are found

increasingly at early stages (W0-W4) and would subside after the inflammatory phase (Henry

and Garner, 2003). Although hydrogel has shown to improve appearance of scarring, Allium

cepa also improves scarring but have a “delayed” healing affect and therefore signs of change

was only picked up after W4. Interestingly, according to Figure 5.1 percentage improvements by

W12 was greater in the treatment group for most of these parameters except for pigmentation.

Future studies may need to increase the study period in order to fully establish the healing

properties of Allium cepa due to “delayed” healing.

64

In 2001 a study was conducted to determine the effectiveness of topical Allium cepa applied

three times daily for 4 weeks, on the appearance and symptomatology of post-surgical scars. The

results were then compared to the results of participants using a topical emollient ointment. No

statistically significant difference was seen in the Allium cepa treatment group, between pre- and

post-treatment evaluations at week 4. However a statistically significant reduction in scar

appearance and symptomatology was found in patients using a petrolatum based ointment

(Jackson and Shelton, 2001).

Despite widespread pigment cell research the melanocyte remains a mysterious cell with

numerous roles controlled by various interlinking factors (Chadwick et al., 2012). Efforts to

promote rapid wound healing and minimize the inflammatory response (W4) within the wound

may prevent abnormalities of pigmentation within the resulting scar. Pigmentation usually

improves at late stages of wound healing and this may suggest why improvement is only

expected after the inflammatory phase, W4 (Baek et al., 2009).

Another possible explanation was that the Cross tabulation method was not used in the study and

participants were randomly assigned to either group. The mentioned parameters were not

comparable between the control and treatment group and this is a factor that may influence the

outcome of the study.

5.3.2 Pliability

Changes in the ratings of the pliability of the scar showed statistically significant differences for

the control and the treatment group throughout the entire study (W0-W4, W0-W8 and W0-W12).

The control group applied only hydrogel to their scar and due to the hydrating, soothing and

antimicrobial qualities of the vehicle; pliability of the scar may have improved (Colledge et al.,

2010). The local application of Allium Cepa to a healed sutured wound could significantly

induce the breaking strength of the wound so it might reduce hardness of the scar (Dunkin et al.,

2007).

5.3.3 Overall opinion

According to the Wilcoxon Signed ranks test the Observer‟s overall opinion of the scar for the

control and treatment group showed statistically significant results through out every set point of

the study at W0-W4, W0-W8 and W0-W12.

65

The p-value for the Mann-Whitney U test showed that there was no statistically significant

difference between the control and treatment group regarding all parameters of the POSAS

Observer scale (vascularity, pigmentation, thickness, relief, pliability, surface area and overall

opinion). No significant difference implies that the treatment group did no better than the control

group. Studies with larger sample sizes and longer follow-up consultation might be needed to

confirm the benefits of Allium cepa according to the Observer scale.

It can be concluded that the results obtained from the POSAS Observer scale illustrates that

Allium cepa did not improve symptoms such as vascularity, pigmentation, thickness, relief and

surface area in the first four weeks (W4) better than hydrogel alone. However, bearing in mind

the late improvement and reaction of Allium cepa which should lend to a longer study period for

more comparative results. Similar results were achieved between Allium cepa and hydrogel with

regards to overall opinion and pliability of the scar.

5.4 POSAS Patient scale

The Patient scale of the POSAS (Appendix E) consists of six questions that the

patient/participant answered in regards to their scar (pain, itching, colour, stiffness, thickness and

regularity and overall opinion). All items were scored on a scale ranging from 1 (“no, not at all”)

to 10 (“yes, very much”).

5.4.1 Pain

Pain is the most common symptom of scar healing. The Friedman test indicated an overall lack

of change within the control (p=0.945) and the treatment group (p=0.733). The mean values for

scar pain within both groups were low at W0, consequently the Friedman test indicates that no

significant change occurred and this illustrates that the degree of pain did not worsen from where

it started at W0. Pain is an early sign of inflammation, and it could take up to 3-6 months for a

new dermal scar to reduce pain (Henry and Garner, 2003). Another possibility may well be that

participants enrolled in the study had an increase in awareness of scar pain and may have

contributed to a psychological effect of increased pain. A longer study period could direct

positive benefits towards scar pain after the inflammatory phase has subsided.

The Mann-Whitney U test illustrated that there was a statistically significant difference between

the control and treatment group at week 0, where mean values recorded were 2.4 for the control

group and 1.45 for the treatment group (Figure 4.12). These values confirm that the control and

treatment group were not comparable to start off with. This may be that the two groups were not

66

being matched up according to pain (Cross tabulation method), but were randomly assigned to

either group. The rest of the results showed no statistically significant difference between the two

groups throughout the 12 week period. These findings might also contribute to the lack of

specification in the inclusion criteria of the age of the dermal scar. Scar treatment differs in terms

of wound healing phases, new and older scars (length of study, number of daily application etc.).

This may influence the outcome of the study and it is therefore suggested that future studies

should consider distinguishing between new and old dermal scars.

5.4.2 Itching

Within the control group the percentage improvement was 19.44%, however there was no

statistically significant change over time for itching in the control group (p=0.073). The results

from the treatment group illustrated a 17.77% improvement, yet there was also no statistically

significant change over time (p=0.452). According to the Mann-Whitney U test, no significant

difference was observed between the two groups at W0 (p=0.314); W4 (p=0.328); W8 (p=0.533)

and W12 (p=0.218). There was no significant improvement which can be attributed to itching

only occurring at later stages of wound healing, and therefore future studies might need a longer

study period to show improvement (Henry and Garner, 2003). Similar results were found by

other studies, where Allium cepa failed to alleviate scar pruritis within 12 weeks of treatment

(Chanprapaph et al., 2012; Draelos et al., 2012; Jackson and Shelton, 2001). Differentiation

between new and old dermal scars might also contribute to the phases of wound healing and

therefore may play a role in the degree of scar itching.

5.4.3 Colour

The results from the control group demonstrated an improvement of 18.73% - this change was

not statistically significant (p=0.205). However within the treatment group an overall

improvement of 45.38% which was astatistically significant change over time (p=0.00). The post

hoc Wilcoxon signed ranks analyses showed that for the treatment group there was statistical

significance throughout every time frame of the study (W0-W4, W0-W8 and W0-W12) however

the control group had no significanct change. According to the Mann-Whitney U test the p-value

was more than 0.05, which indicates that there was no significant difference between the two

groups. Despite the lack of significant difference, the results showed a distinguishable trend of

greater improvement for Allium cepa against hydrogel.

A possible reason for this finding could include that Allium cepa is useful in reducing

neoangiogenesis in scars, resulting in the clinical improvement of skin vascularity

67

(Draelos, 2008). Another possibility could be that the quercetin in Allium cepa causes an anti-

inflammatory effect by inhibiting lipopolysaccharide-induced tumor-necrosis factor-alpha (TNF-

α) production which could result in faded scar colour (Boots et al., 2008).

According to Taylor (2008), these results might perhaps be due to the fact that the significance of

quercetin‟s cellular effects seems to reside in its anti-histamine properties. The theory behind this

is that a compound that blocks histamine release may normalise or decrease collagen production

by fibroblasts, subsequently resulting in reduced dermal scar volume and relative normalisation

of the scar maturation process. The cosmetic result is a decrease in scar erythema (Taylor, 2008).

5.4.4 Stiffness

The control group showed an improvement of 18.01% and illustrated a statistically significant

change over time for scar stiffness (p=0.011). In the treatment group there was an overall

substantial improvement of 55.5% and a statistically significant change was attained (p=0.00)

regarding the stiffness of the scar. Both the control and treatment groups numerical mean value

were similar at W0 (5.55 in the control group and 5.85 in the treatment group). According to the

post-hoc Wilcoxon signed ranks analyses there was no statistically significance achieved for the

control group between W0-W4 The rest of the time frames were statistically significant (W0-

W8, W0-W12). The treatment group on the other hand, demonstrated statistically significant

improvement in scar thickness according to the Wilcoxon signed ranks test (W0-W4, W0-W8

and W0-W12).

The control group applied only hydrogel to their scar and due to the hydrating, soothing and

antimicrobial qualities of the vehicle, stiffness of the scar improved according to the participant

but took longer to show improvement and improvement was only seen between W0-W8 onwards

(Colledge et al., 2010). The local application of Allium Cepa to a healed sutured wound could

reduce the breaking strength of the wound so it might reduce hardness of the scar (Dunkin et al.,

2007).

The Mann-Whitney U test illustrated that there was no statistically significant difference

between the control and treatment group at week 0, week 4 or week 8, which indicates that the

two groups were comparable to start off with (Table 4.26). However by week 12 there was a

statistically significant difference between the treatment and control group, which means that

they ended off non-comparable.

68

5.4.5 Thickness

The results from the control group demonstrated an improvement of 47.88% and there was

statistically significant change with regards to scar thickness (p=0.001). Within the treatment

group an improvement of 60% was achieved and a statistically significant change happened over

time (p=0.000). The Mann-Whitney U analysis demonstrated that the groups started off

comparable and ended off non-comparable at the end of the study (W0 (p=0.445); W4

(p=0.405); W8 (p=0.452) and W12 (p=0.008)). Due to the significant difference at W12, the

results showed a greater improvement for Allium cepa compared to hydrogel in scar thickness

(Figure 5.2).

Allium cepa is classed as a PGF ß1 antagonist. This can help explain the results obtained for scar

thickness. In 2007, rat skin-biopsy models were exposed to different topical scar treatments and

assessed for immunohistochemical and ultrastructural changes in scar formation after treatment.

The Allium cepa group had the thinnest (normal epidermis) and the appearance of keratinocytes

forming the epidermis was close to normal. Due to the PGF ß1 antagonist properties of Allium

cepa scar thickness was affected and improved by 60% (Ralf, 2007).

5.4.6 Irregularity

Within the control group an improvement of 25.61% was achieved for scar irregularity and a

statistically significant change occurred over time (p=0.000). According to the Wilcoxon signed

ranks analyses for the control group, no statistically significant difference was found at the

beginning of the study or between W0-W4, and significant results were only achieved between

W0-W8 and W0-W12. The treatment group on the other hand, demonstrated an improvement of

51.53% as well as statistically significant change (p=0.000). The Wilcoxon signed ranks test for

the treatment group was shown to change irregularity of the scar between every consultation of

the study (W0-W4; W0-W8; W0-W12). This result indicates that for the treatment group there

was felt to be a change in surface irregularities according the participant throughout every time

frame of the study.

Allium cepa induces MMP-1 expression which has a key role in ECM remodeling and could

result in reduced scar irregularity (Cho et al., 2010). The vehicle (hydrogel) in both groups might

have played a role in soothing and hydrating the scar leading to reduced scar irregularities.

The Mann-Whitney U test showed a p-value greater than 0.05 at every consultation of the study,

which indicates that there was no difference between the two groups.

69

Objectivity and validity of subject self-rating scales for assessing improvement differences

between groups in this type of study is questionable since the participants were not completely

blinded to treatment due to the smell and colour of Allium cepa and might therefore have been

biased. Despite this the POSAS Patient scale is an useful tool for providing meaningful

information from the viewpoint of the participant‟s satisfaction, even though it may not be totally

reliable (Draelos, 2008).

5.4.7 Overall opinion

The overall opinion for the control group improved by 25.36% and illustrated a statistically

significant change over time (p=0.000). Within the treatment group an improvement of 54.61%

was achieved and statistically significant change occurred over time (p=0.000). Results of the

Wilcoxon Signed Ranks test showed that the change in the overall opinion for the control and

treatment group started from the beginning of the study throughout (W0-W4; W0-W8; W0-

W12). The Mann Whitney U analysis illustrated that the p-value at W12 was less than 0.05,

therefore a statistically significant difference was achieved between the control and treatment

group by week 12 only (W0 (p=0.168); W4 (p=0.292); W8 (p=0.495) and W12 (p=0.036)).

From these results we can assume that in general, participants in either treatment or control

group felt satisfied with their scar‟s overall appearance at week 12. Due to the significant

difference at W12, the results showed a greater improvement for Allium cepa compared to

hydrogel in participant‟s overall opinion of their scar.

It can be concluded that the results obtained from the POSAS Patient scale illustrates that Allium

cepa improved stiffness, thickness and the patient‟s overall opinion better than hydrogel. Other

areas that demonstrated improvement was scar colour and scar irregularities. Symptoms such as

scar pain and itching did not show to improve at all, in either group.

5.5 Digimizer®

5.5.1 Surface area and length

With regards to surface area the control group had an overall improvement of 44.85% and

showed a statistically significant change over time (p=0.000). Within the treatment group an

improvement of 48.43% was achieved and a statistically significant change occurred (p=0.000).

These results indicate that there was a change or improvement for both groups in surface area of

the scar. The Wilcoxon signed ranks test showed that the change for the control group occurred

between every follow up consultation (W0-W4, W0-W8, and W0-W12). The treatment group on

70

the other hand, was shown to improve or change the surface area of the scar only between W0-

W8 and W0-W12 . In majority of subjects the benefits of Allium cepa are only fully defined

from eight weeks of application and onwards (Draelos, 2008).

When measuring the length of the scar, the control group had an overall improvement of 17.19%

and there was a statistically significant change over time (p=0.023). The treatment group

improved by 10.78% and demonstrated a positive change over time (p=0.006). The change in the

length of the scar, for both the control and treatment group according to the Wilcoxon Signed

ranks test was shown to have occurred between week 8 and week 12 (W0-W8; W0-W12). There

was no change found from the start of the study until week four (W0-W4). A likelihood for this

outcome could be explained by Arem and Madden‟s tension theory, which was given validity

when the results of their study confirmed that a physical change of scar length could be achieved

through the application of local and topical mobilization (topical application of gel) (Arem and

Madden, 1976).

The Mann Whitney U test illustrated that in scar length and surface area there was no statistically

significant difference between the control and treatment group. Despite positive results there was

no statistically significant difference between hydrogel and Allium cepa with regards to scar

length and surface area.

5.5.2 Width

The control group showed statistically significant change (p=0.019), however there was no

percentage improvement with regards to mean value measurements (0%). Interestingly the

treatment group had no statistically significant change (p=0.115), but illustrated an overall

improvement of 17.587%. The Wilcoxon signed ranks test showed that there was no statistically

significant change between time frames for the control group (W0-W4, W0-W8 and W0-W12).

However the treatment group showed significant change between W0-W8, the rest was

insignificant. The Mann Whitney U test illustrated that there was no statistically significant

difference between the control and treatment group. Measuring scar width with Digimizer®

may

not be a reliable tool because if 0.1mm measuring accuracy is missed it could influence the

results and possible outcomes. Future studies may lend to a different measuring tool with regards

to scar width.

A scar is formed through a highly organized sequence of physiologic events. Many factors can

contribute to scar formation including ethnicity, genetic influences, anatomical region affected,

71

wound depth, injury type, the presence of infection and prolonged immune responses (Singer and

McClain, 2002). Despite these factors, 12% Allium cepa MT in hydrogel has shown to improve

scar stiffness, thickness and the overall opinion of participants better than hydrogel. However

scar colour and irregularity also demonstrated improvement with Allium cepa more than with

hydrogel.

5.6 Summary of Results

5.6.1 POSAS Observer scale

Relevant to parameters measured using the POSAS Observer Scale, each parameter measured

was found to yield significant improvement for each group, rendering both the treatment and

control interventions effective in improvement of appearance criteria as assessed by the observer.

With respect to average percentage improvements (Figure 5.1), only the measure related to

pigmentation was found to have a greater average degree of improvement for the control

(hydrogel) group versus the treatment (hydrogel and Allium cepa) group. All other parameters

demonstrated a greater degree of average percentage score improvement relevant to the

treatment group. There was, however, found to be no statistically significant difference between

the treatment and control group for any of these parameters.

Although there is no significant difference in the results, there is a distinguishable trend of

greater average percentage improvement for the treatment group (43.50%) compared to that of

the control group (34.89%).

Figure 5. 1 Percentage improvements in POSAS Observer Scale

0

10

20

30

40

50

60

Percentage improvements in POSAS Observer scale

Control Group

Treatment Group

72

5.6.2 POSAS Patient scale

In terms of measures associated with the POSAS Patient scale, participants in the control and

treatment group both experienced significant improvements in the stiffness, thickness,

irregularity and overall opinion related to their scarring (p<0.05). No improvement was

registered for the parameter of pain at the end of 12 weeks for either group. Neither group

experienced any significant improvement in itching, while the control group appeared to show

no improvement in colour of the scar (p=0.205) versus the treatment group which did (0.000),

however with no significant differences found between the two groups after 12 weeks.

According to Figure 5.2 the treatment group tends to show a greater average percentage score

improvement per parameter of the POSAS Patient scale. With the significant improvements

demonstrated between the two groups in stiffness, thickness and overall opinion, there is also a

distinguishable trend of greater average percentage improvement for the treatment group

(40.69%) compared to that of the control group (19.43%).

Figure 5.2 Percentage improvements in the POSAS Patient scale

5.6.3 Digimizer®

During measurement, statistically significant change occurred for both the treatment and control

group in length and surface area of the scar. Relative to these parameters the Wilcoxon signed

ranks test only started showing improvement from W0-W8 and W0-W12, and no change was

observed at the beginning of the study W0-W4.

0

10

20

30

40

50

60

70

Percentage improvements in POSAS Patient scale

Control Group

Treatment Group

73

Figure 5.3 represents the average percentage improvement for each Digimizer® parameter in

each group.

Figure 5.3 Digimizer® percentage improvements

0

10

20

30

40

50

60

Surface area Length Width

Percentage improvements for Digimizer®

Control group

Treatment group

74

CHAPTER SIX

CONCLUSION AND RECOMMENDATIONS

6.1 Conclusion

The study aimed to ascertain the effect of hydrogel medicated with Allium cepa mother tincture

(12%) on the appearance of CS scars. It was found that both hydrogel (control) and hydrogel

medicated with Allium cepa (12%) (treatment) were able to improve the general appearance of

scars in all parameters measured except for sensations of pain and itching. When compared to

the control hydrogel, Allium cepa (12%) appeared to significantly improve the patient‟s own

perception of scar stiffness (p=0.008), thickness (p=0.008) and overall opinion thereof

(p=0.036). Despite the lack of significant difference between groups, Allium cepa (12%) appears

to improve the vascularity, thickness, relief, pliability, surface area and colour of scars to a

greater extent than the control hydrogel and it is evident that more research over a longer period

of time is required.

Using the POSAS Observer scale it was determined that both the control and treatment groups

improved significantly in all measured parameters but that in all but one parameter

(pigmentation) the treatment group tended to show greater degrees of improvement than the

control by the end of the study. The average improvement of the treatment group as measured by

the observer for all parameters was however found not to be statistically different when

compared to that of the control group.

The POSAS Patient scale demonstrated a significant difference in improvement for both groups

with respect to stiffness, thickness and overall opinion (p<0.05). Colour of scars was found to

improve significantly for the treatment group but not for the control. In addition, the treatment

group was found to have a significantly higher improvement than the control group in all other

parameters of this scale.

Allium cepa (12%) was found not to have any effect on pain or itching of the scar, likely due

tolower levels of pain and itching experienced by participants at the onset of the study. . The

total surface area of the scars improved for both groups, however acknowledged inaccuracies

associated with this means of measurement relative to the actual size of the scars should be

noted.

75

Due to the hydrating, soothing and anti-microbial nature of hydrogel, improvement in the

appearance of CS was noted in this study for the control group. Illustrating that hydrogel on its

own has therapeutic effects on scar tissue. It is however evident that Allium cepa (12%) may

yield a safe additive option for the additional potential improvement of scars when combined

with hydrogel. The treatment had no unwanted side effects.

This study arrived at potentially useful findings that may be used in the construction of further

research studies and may lead to a body of knowledge for the homoeopathic MT, Allium cepa on

the appearance of CS.

6.2 Recommendations

Should a further study be conducted these are the following recommendations to be made as a

result of the experience of the study:

The duration of the study period should be extended given that in certain variables of this

study, statistically significant improvement only occurred by week 4. In order to ascertain a

more complete assessment of the effect of treatment a longer study period should be required

given the phases of wound healing and factors contributing to scarring and the time period

required to evaluate the effect of Allium cepa.

The sample size should be increased in order for the results to gain statistical significance in

terms of parametric analyses.

Due to the size of the scars, measurement procedures and tools need to be carefully

considered such that slight changes of measure by the researcher do not interfere with the

significance of results obtained.

It was noted that scar treatment is determined by various phases of wound healing and thus

the age of the scar play a contributing role. An age criteria of scars should be included in this

study, for example if it is a new dermal scar (12 weeks post-surgery) or an old scar (12 years

post-surgery).

Future researchers may want to limit or stratify their study sample groups according to

specific age groups, e.g. 20-30 years old or 31-40 years for standardisation for age of the

dermal scar and severity of the scar.

76

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APPENDIX A

Advertisement

o Do you have a caesarean section scar that has been there for more than 8 weeks?

o Are you between the ages of 18-50?

If you answered YES to the above, then you may qualify to participate in a research study

being conducted by the Department of Homoeopathy at the University of Johannesburg

Health Centre.

The study is entiled:

“The efficacy of Allium cepa 12% hydrogel on caesarean section scars”

Ethical clearance number: HDC 01-66-2014

Researchers‟s name: Alicia Gerber

Contact number: 07102083515

DO YOU HAVE A

CAESAREAN SECTION SCAR?

86

APPENDIX B

Participant information form

Dear Participant

My name is Alicia Gerber. I am in my final year of my studies in homoeopathy at the University

of Johannesburg. A requirement for the completion of my Masters Degree in homoeopathy

(MTech Homoeopathy) is to conduct a research study. The purpose of the study is to determine

the efficacy of Allium cepa on the appearance of Caesarean section scars.

The aim of the study is to determine the efficacy of 12% (v/v) Allium cepa MT in a hydrogel

solution on the appearance of caesarean section scars for 12 weeks. The POSAS will be used to

analyse any improvement on the appearance of your caesarean scar together with digital

photographical evidence.

Allium cepa is a homoeopathic remedy prepared from the red onion bulb; research has shown a

possible positive effect of this remedy on the appearance of scars. Allium cepa will be prepared

homoeopathically, therefore there are no undesirable side effects known with its application.

I invite you to participate in my research study if you:

Are female;

Between the ages of 18-50 years;

Have a vertical or transverse surgical scar which was completed with absorbable suturing,

and

Are at least 8 weeks post-surgery.

You will not be able to participate if you:

Have a history of onion allergy;

Use any other topical treatments to the area;

Have general surgical complications such as high temperature (fever), pain, increased

perspiration, tiredness (fatigue) and signs of post-operative infections, and/or

Report of local surgical complications such as redness, heat, infection, sepsis, keloid scar

formation and strophic or hypertrophic scars.

87

Forty female participants will be divided into two groups of twenty each. The one group will

receive unmedicated hydrogel and the other group will receive hydrogel medicated with Allium

cepa MT. Either group will not be identified to you or the researcher before or during the time of

the study. You will therefore not know whether the homoeopathic remedy is incorporated into

the gel that you are using. We refer to this design as a double blinded study which ensures that

the data gathered by the researcher will not be biased. If you are in the control group and the

study has shown to be beneficial, you will also receive Allium cepa MT hydrogel.

This 12 week study will be conducted at the University of Johannesburg, Health Centre,

Doornfontein. At the first consultation (week 0) the information and consent form will be

explained and read to you, after the study is fully understood you will be requested to sign the

consent form. On the first consultation (week 0) a case taking form will also be completed by the

researcher, with measuring of Vital signs (Blood pressure, Pulse rate, Respiratory rate and

Temperature) together with a general examination and a quick questionnaire to assess the impact

of the scar on your life. Another form will be completed by both the researcher and you, called

the Patient and Observer Scar Assessment Scale (POSAS). This scale will measure the degree of

pain, itching, stiffness, thickness, regularity and colour experienced by you and signs like

pigmentation, thickness, pliability, surface area, relief and vascularity by the researcher. A

photograph will then be taken by the researcher of your scar; this will be stored electronically on

a programme called Digimizer® and used to analyse and compare study outcome. There will be

three follow-up appointments in the 12 week period; these will be at week 4, week 8 and week

12, at these consults you will also receive your 150ml Hydrogel containers with a 5ml

medicating spoon. 5ml of treatment needs to be applied twice a day for twelve weeks. At these

follow up appointments a brief physical exam will be done together with the completion of the

POSAS assessment scale and a photograph will be taken and loaded onto Digimizer®.

Directions for use

1. You are advised not to apply any other cream/lotion/oil/ointment to the treatment area, as it

could affect the outcome of the results, if so you will be excluded.

2. You should apply the gel on the demarcated treatment area twice a day for 12 weeks.

3. You are requested to keep the 150ml gel container lid closed after usage, out of sun exposure

and in a cool dark cupboard.

4. You should inform the researcher if any of the following occurs:

88

Unfavourable changes to the skin

Discomfort attributed to the gel.

89

APPENDIX C

Consent form

I, _________________________________________________, hereby confirm that I understand

and consent to the following (please tick):

1. Involvement in a research study and have no presumption about the result.

2. I will apply the gel as explained in the directions of use.

3. I am aware that my caesarean section scar may or may not show any improvement at the

end of the research study.

4. I am free to withdraw from the study at any time without prejudicing any treatment that is

required for existing or future medical conditions.

5. My caesarean scar may be physically measured and I hereby consent to photographs

being taken of my scars that will only include the borders of the abdomen which will be

contained within the periphery of the photograph. I understand that these photographs

will be stored appropriately, treated with the utmost confidentiality and be part of my

research participation record. I understand that all efforts will be made to conceal my

identity but that full confidentiality cannot be guaranteed.

6. I understand that I will be given an opportunity to view any photographs that will be used

for any publication at any time and can request changes or agree / disagree to their

publication.

7. I hereby give consent for the photographs to be used for (please initial):

Approved research purposes & publication [Initial:________]

This may involve the photographic images being used in the dissertation associated with

this research study or in subsequent medical publications, journals, textbooks, conference

material, e-publications and on the internet. Images will be seen by readers and

examiners of the dissertation including health professionals and researchers who use any

publications in their professional education. The images may be seen by the general

public. Images will not be used with identifying information such as name, however, full

confidentiality is not guaranteed.

90

By signing the form below you indicate that you are satisfied with the intention of the study and

that the researcher has explained all matters contained to you so that you are satisfied with the

process of the study. All data collected from you will be kept confidential and none of your

identifying data will be used in any publication related to this research. To maintain privacy, all

other documents apart from this one will be labelled using a participant number. If you are

uncertain about any aspect please feel free to discuss it with me or the supervisor (contact details

below).

____________________ ________________________

Participant Signature Date

I, the researcher, have fully explained the methods and purpose of the treatment in the study. I

will answer any questions that may arise during the course of the study to the best of my

abilities.

____________________ ________________________

Signature (Researcher) Date

Alicia Gerber – Phone: 0712083515

Supervisor: Dr Neil Gower - Phone: 0115596779

Participant Number: _________

91

APPENDIX D

Case taking form

Participant Number: Date:

Race: A B I W C Age:

Information sheet

Date of Surgery:

Type of incision:

Type of suturing:

Number of previous CS:

Scar Appearance:

Normal Hypertrophic Atrophic

History of onion allergy? Yes No

Physical examination

VITALS:

Blood pressure:

Heart rate:

Respiratory rate:

Temperature:

GENERAL

INSPECTION:

CAJCOLD C A J C O L D

Subjective quality of life assessment

Are you constantly conscious about your caesarean section scar? YES NO

Is the scar affecting your choice of your social activities? YES NO

Are you avoiding certain situations to prevent exposure of your

scar?

YES NO

Do you feel less confident about your body due to the scar? YES NO

Is the scar uncomfortable and preventing you from enjoying daily

activities?

YES NO

Does the scar affect your sex life? YES NO

92

APPENDIX E

POSAS Observer and Patient scale

93

94

APPENDIX F

STATKON statistics tables

1. POSAS Observer scale

1.1 Vascularity

Table F. 1 POSAS Observer scale vascularity mean values

Observer scale -Vascularity- consultation1

Mean Min Max Std.Dev

A 4.27 1 9 2.492

B 3.9 1 7 1.651

Observer scale -Vascularity- consultation 2

A 3.55 1 9 2.523

B 3.5 2 6 1.504

Observer scale -Vascularity- consultation 3

A 2.65 1 7 1.694

B 2.55 1 5 1.276

Observer scale -Vascularity- consultation 4

A 2.5 1 6 1.433

B 2.15 1 5 1.04

Table F. 2 POSAS Observer scale vascularity test for normality-Shapiro Wilk

Group Group

Sig.

Observer scale -Vascularity- consultation1 A .045

B .377

Observer scale -Vascularity- consultation 2 A .014

B .004

Observer scale -Vascularity- consultation 3 A .006

B .017

Observer scale -Vascularity- consultation 4 A .019

B .002

Table F. 3 POSAS Observer scale Vascularity Mann Whitney U test

Obs_Vas1

Observer

scale

Obs_Vas2

Observer

scale

Obs_Vas3

Observer

scale

Obs_Vas4

Observer

scale

Asymp.

Sig. (2-

tailed)

.858 .641 .900 .498

95

Table F. 4 POSAS Observer scale Vascularity Friedman test

A N 20

Chi-Square 29.975

df 3

Asymp. Sig. .000

B N 20

Chi-Square 36.939

df 3

Asymp. Sig. .000

Table F. 5 POSAS Observer scale vascularity Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.684b -3.330

b -3.330

b

Asymp. Sig. (2-tailed) .007 .001 .001

B Z -1.358b -3.703

b -3.559

b

Asymp. Sig. (2-tailed) .174 .000 .000

1.2 Pigmentation

Table F. 6 POSAS Observer scale pigmentation Mean values

Observer scale -Pigmentation- consultation1

Mean Min Max Std.Dev

A 4.14 1 10 2.8

B 4 2 7 1.522

Observer scale -Pigmentation-consultation 2

A 3.35 1 9 2.641

B 3.45 1 6 1.538

Observer scale -Pigmentation-consultation 3

A 2.5 1 7 1.762

B 2.7 1 5 1.218

Observer scale -Pigmentation-consultation 4

A 2.3 1 6 1.652

B 2.2 1 5 1.056

Table F. 7 POSAS Observer scale pigmentation test for normality Shapiro Wilk test

Group Group

Sig.

Observer scale -Pigmentation- consultation1 A .008

B .065

Observer scale -Pigmentation- consultation 2 A .001

B .060

Observer scale -Pigmentation- consultation 3 A .002

B .062

Observer scale -Pigmentation- consultation 4 A .001

B .006

96

Table F. 8 POSAS Observer scale pigmentation Mann Whitney U test

Obs_Pig1

Observer

scale

Obs_Pig2

Observer

scale

Obs_Pig3

Observer

scale

Obs_Pig4

Observer

scale

Asymp.

Sig. (2-

tailed)

.540 .353 .331 .682

Table F. 9 POSAS Observer scale Pigmentation Friedman test

A N 20

Chi-Square 26.097

df 3

Asymp. Sig. .000

B N 20

Chi-Square 31.091

df 3

Asymp. Sig. .000

Table F. 10 POSAS Observer scale pigmentation Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.694b -3.132

b -3.255

b

Asymp. Sig. (2-

tailed) .007 .002 .001

B Z -1.707b -3.345

b -3.671

b

Asymp. Sig. (2-

tailed) .088 .001 .000

1.3 Thickness

Table F. 11 POSAS Observer scale thickness mean values

Observer scale -Thickness- consultation1

Mean Min Max Std.Dev

A 4.36 1 10 2.871

B 4.15 2 8 1.663

Obs_Vas2 Observer scale -Thickness- consultation 2

A 3.75 1 9 2.653

B 3.6 2 6 1.465

Obs_Vas3 Observer scale -Thickness- consultation 3

A 3.3 1 9 2.577

B 2.85 2 6 1.089

Obs_Vas4 Observer scale -Thickness- consultation 4

A 3.2 1 9 2.587

B 2.45 1 6 1.191

97

Table F. 12 POSAS Observer scale thickness test for normality Shapiro Wilk test

Group Group

Sig.

Observer scale -Thickness- consultation1 A .002

B .024

Observer scale -Thickness- consultation 2 A .002

B .011

Observer scale-Thickness- consultation 3 A .002

B .000

Observer scale -Thickness- consultation 4 A .001

B .000

Table F. 13 POSAS Observer scale thickness Mann Whitney U test

Obs_Thick1

Observer scale

Obs_Thick2

Observer scale

Obs_Thick3

Observer scale

Obs_Thick4

Observer scale

Asymp. Sig.

(2-tailed) .599 .544 .615 .779

Table F. 14 POSAS Observer scale thickness Friedman test

A N 20

Chi-Square 24.239

df 3

Asymp. Sig. .000

B N 20

Chi-Square 41.408

df 3

Asymp. Sig. .000

Table F. 15 POSAS Observer scale thickness Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.725b -3.331

b -3.179

b

Asymp. Sig. (2-tailed) .006 .001 .001

B Z -2.230b -3.621

b -3.893

b

Asymp. Sig. (2-tailed) .026 .000 .000

98

1.4 Relief

Table F. 16 POSAS Observer scale relief mean values

Observer scale -Relief- consultation1

Mean Min Max Std.Dev

A 4.32 2 10 2.662

B 3.95 2 10 1.791

Observer scale -Relief- consultation 2

A 3.75 1 10 2.693

B 3.65 2 9 1.814

Observer scale –Relief- consultation 3

A 3.15 1 10 2.54

B 2.9 1 8 1.518

Observer scale -Relief- consultation 4

A 3 1 9 2.428

B 2.3 1 7 1.49

Table F. 17 POSAS Observer scale relief test for normality Shapiro Wilk test

Group Group

Sig.

Observer scale -Relief- consultation1 A .000

B .001

Observer scale -Relief - consultation 2 A .001

B .002

Observer scale-Relief - consultation 3 A .000

B .001

Observer scale -Relief- consultation 4 A .000

B .000

Table F. 18 POSAS Observer scale relief Mann Whitney U test

Obs_Rel1

Observer

scale

Obs_Rel2

Observer

scale

Obs_Rel3

Observer

scale

Obs_Rel4

Observer

scale

Asymp.

Sig. (2-

tailed) .718 .560 .656 .449

Table F. 19 POSAS Observer scale Friedman test

A N 20

Chi-Square 32.980

df 3

Asymp. Sig. .000

B N 20

Chi-Square 39.735

df 3

Asymp. Sig. .000

99

Table F. 20 POSAS Observer scale Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.970b -3.654

b -3.697

b

Asymp. Sig.

(2-tailed) .003 .000 .000

B Z -1.732b -3.231

b -3.912

b

Asymp. Sig.

(2-tailed) .083 .001 .000

1.5 Pliability

Table F. 21 POSAS Observer scale pliability mean values

Observer scale -Pliability- consultation1

Mean Min Max Std.Dev

A 4.45 2 10 2.483

B 4.55 2 10 1.932

Observer scale -Pliability- consultation 2

A 3.75 1 10 2.693

B 3.8 1 9 1.881

Observer scale -Pliability- consultation 3

A 3.1 1 10 2.573

B 3 1 8 1.686

Observer scale -Pliability- consultation 4

A 2.95 1 9 2.46

B 2.35 1 8 1.663

Table F. 22 POSAS Observer Scale pliability normality test Shapiro Wilk

Group Group

Sig.

Observer scale -Pliability- consultation1 A .003

B .001

Observer scale -Pliability- consultation 2 A .001

B .026

Observer scale-Pliability- consultation 3 A .000

B .004

Observer scale -Pliability- consultation 4 A .000

B .000

Table F. 23 POSAS Observer scale pliability Mann Whitney U test

Obs_Pliab1

Observer

scale

Obs_Pliab2

Observer

scale

Obs_Pliab3

Observer

scale

Obs_Pliab4

Observer

scale

Asymp.

Sig. (2-

tailed)

.452 .400 .561 .575

100

Table F. 24 POSAS Observer scale pliability Friedman test

A N 20

Chi-Square 33.090

df 3

Asymp. Sig. .000

B N 20

Chi-Square 41.180

df 3

Asymp. Sig. .000

Table F. 25 POSAS Observer scale pliability Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.944b -3.450

b -3.580

b

Asymp.

Sig. (2-

tailed)

.003 .001 .000

B Z -2.585b -3.580

b -3.894

b

Asymp.

Sig. (2-

tailed)

.010 .000 .000

1.6 Surface area

Table F. 26 POSAS Observer scale surface area mean values

Observer scale -Surf- consultation1

Mean Min Max Std.Dev

A 4.23 1 10 2.743

B 4.8 2 10 2.419

Observer scale -Surf- consultation 2

A 3.55 1 10 2.819

B 4.3 1 9 2.473

Observer scale -Surf- consultation 3

A 3.2 1 10 2.505

B 3.2 1 8 1.989

Observer scale -Surf- consultation 4

A 3.05 1 9 2.481

B 2.8 1 8 1.824

101

Table F. 27 POSAS Observer scale surface area test for normality Shapiro Wilk test

Group Group

Sig.

Observer scale -Surf- consultation1 A .004

B .008

Observer scale -Surf- consultation 2 A .001

B .035

Observer scale-Surf- consultation 3 A .000

B .001

Observer scale -Surf- consultation 4 A .001

B .002

Table F. 28 POSAS Observer scale surface area Mann Whitney U test

Obs_Surf1

Observer

scale

Obs_Surf2

Observer

scale

Obs_Surf3

Observer

scale

Obs_Surf4

Observer

scale

Asymp.

Sig. (2-

tailed)

.323 .217 .716 .945

Table F. 28 POSAS Observer scale surface area Friedman test

A N 20

Chi-Square 18.714

df 3

Asymp. Sig. .000

B N 20

Chi-Square 38.098

df 3

Asymp. Sig. .000

Table F. 29 POSAS Observer scale surface area Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.623b -2.793

b -3.092

b

Asymp.

Sig. (2-

tailed)

.009 .005 .002

B Z -2.140b -3.447

b -3.551

b

Asymp.

Sig. (2-

tailed)

.032 .001 .000

102

1.7 Overall opinion

Table F. 30 POSAS Observer scale Overall opinion mean values

Observer scale -Overall- consultation1

Mean Min Max Std.Dev

A 4.559 1 10 2.702

B 4.45 2 10 1.791

Observer scale -Overall consultation 2

A 3.75 1 9 2.552

B 3.85 2 9 1.694

Observer scale -Overall- consultation 3

A 3.35 1 9 2.346

B 3.1 1 8 1.619

Observer scale -Overall- consultation 4

A 3.25 1 9 2.381

B 2.45 1 6 1.234

Table F. 31 POSAS Observer scale overall opinion test for normality Shapiro Wilk

Group Group

Sig.

Observer scale -Overal- consultation1 A .009

B .004

Observer scale -Overal- consultation 2 A .001

B .006

Observer scale-Overal- consultation 3 A .001

B .009

Observer scale -Overal- consultation 4 A .001

B .001

Table F. 32 POSAS Observer scale overall opinion Mann Whitney U test

Obs_Over1

Observer

scale

Obs_Over2

Observer

scale

Obs_Over3

Observer

scale

Obs_Over4

Observer

scale

Asymp.

Sig. (2-

tailed)

.634 .334 .879 .397

Table F. 33 POSAS Observer scale overall opinion Wilcoxon signed ranks test

A N 20

Chi-Square 36.737

df 3

Asymp. Sig. .000

B N 20

Chi-Square 44.018

df 3

Asymp. Sig. .000

103

2. POSAS Patient scale

2.1 Pain

Table F. 34 POSAS Patient scale pain mean values

Pat_Pain1- consultation1

Mean Min Max Std.Dev

A 2.4 1 6 1.875

B 1.45 1 7 1.468

Pat_Pain2 -Overall consultation 2

A 2.45 1 6 1.638

B 1.85 1 9 2.033

Pat_Pain3consultation 3

A 2.4 1 8 2.088

B 1.5 1 5 1

Pat_Pain4- consultation 4

A 2.45 1 8 2.164

B 1.5 1 8 1.573

Table F. 35 POSAS Patient scale pain test for normality Shapiro Wilk

Group Group

Sig.

Pat_Pain1 Patient scale -Pain- consultation1 A .000

B .000

Pat_Pain2 Patient scale -Pain- consultation 2 A .000

B .000

Pat_Pain3 Patient scale -Pain- consultation 3 A .000

B .000

Pat_Pain4 Patient scale -Pain- consultation 4 A .000

B .000

Table F. 36 POSAS Patient scale pain Mann Whitney U test

Pat_Pain1

Patient

scale

Pat_Pain2

Patient

scale

Pat_Pain3

Patient

scale

Pat_Pain4

Patient

scale

Asymp.

Sig. (2-

tailed)

.037 .085 .266 .116

Table F. 37 POSAS Patient scale pain Friedman test

A N 20

104

Chi-Square .375

df 3

Asymp. Sig. .945

B N 20

Chi-Square 1.286

df 3

Asymp. Sig. .733

2.2 Itching

Table F. 38 POSAS Patient scale Itching mean values

Pat_Itch1- consultation1

Mean Min Max Std.Dev

A 3.6 1 10 3.218

B 2.25 1 10 2.425

Pat_Itch2 -Overall consultation 2

A 2.95 1 7 2.212

B 2.3 1 8 2.386

Pat_Itch3consultation 3

A 2.85 1 8 2.455

B 2.05 1 7 1.572

Pat_Itch4- consultation 4

A 2.9 1 8 2.553

B 1.85 1 7 1.843

Table F. 39 POSAS Patient scale Itching test for normality Shapiro Wilk

Table F. 40 POSAS Patient scale Mann Whitney U test

Pat_Itch1

Patient scale

Pat_Itch2

Patient scale

Pat_Itch3

Patient scale

Pat_Itch4

Patient scale

Asymp.

Sig. (2-

tailed)

.314 .328 .533 .218

Group Group

Sig.

Pat_Itch1 Patient scale -Itching- consultation1 A .000

B .000

Pat_Itch2 Patient scale -Itching- consultation 2 A .001

B .000

Pat_Itch3 Patient scale -Itching- consultation 3 A .000

B .000

Pat_Itch4 Patient scale -Itching- consultation 4 A .000

B .000

105

Table F. 41 POSAS Patient scale itching Friedman test

A N 20

Chi-Square 7.010

df 3

Asymp. Sig. .072

B N 20

Chi-Square 2.630

df 3

Asymp. Sig. .452

Table F. 42 POSAS Patient scale itching Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -1.136b -2.007

b -1.711

b

Asymp.

Sig. (2-

tailed)

.256 .045 .087

B Z -.086c -.239

b -.933

b

Asymp.

Sig. (2-

tailed)

.931 .811 .351

2.3 Colour

Table F. 43 POSAS Patient scale colour mean values

Pat_Col1- consultation1

Mean Min Max Std.Dev

A 5.23 1 10 2.742

B 6.5 2 10 2.482

Pat_Col2 -consultation 2

A 4.45 1 8 2.259

B 5.15 1 8 1.843

Pat_Col3consultation 3

A 4.15 1 8 2.207

B 4.2 1 9 2.067

Pat_Col4- consultation 4

A 4.25 1 8 2.197

B 3.55 1 9 2.064

Table F. 44 POSAS Patient scale colour test for normality Shapiro Wilk test

Group Group

Sig.

Pat_Col1 Patient scale -Colour- consultation1 A .000

B .000

Pat_Col2 Patient scale -Colour- consultation 2 A .001

B .000

Pat_Col3 Patient scale -Colour- consultation 3 A .000

B .000

106

Pat_Col4 Patient scale -Colour- consultation 4 A .000

B .000

Table F. 45 POSAS Patient scale colour Mann Whitney U test

Pat_Col1

Patient

scale

Pat_Col2

Patient

scale

Pat_Col3

Patient

scale

Pat_Col4

Patient

scale

Asymp.

Sig. (2-

tailed)

.157 .279 .870 .302

Table F. 46 POSAS Patient scale colour Friedman test

A N 20

Chi-Square 4.579

df 3

Asymp. Sig. .205

B N 20

Chi-Square 31.817

df 3

Asymp. Sig. .000

Table F. 47 POSAS Patient scale colour Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -1.512b -1.779

b -1.690

b

Asymp.

Sig. (2-

tailed)

.131 .075 .091

B Z -2.475b -3.132

b -3.678

b

Asymp.

Sig. (2-

tailed)

.013 .002 .000

107

2.4 Stiffness

Table F. 48 POSAS Patient scale stiffness mean values

Pat_Stiff1- consultation1

Mean Min Max Std.Dev

A 5.55 1 10 2.365

B 5.85 1 10 2.368

Pat_Stiff2 -consultation 2

A 4.95 1 8 2.259

B 4.15 1 8 2.11

Pat_Stiff3consultation 3

A 4.5 1 8 2.164

B 3.75 1 10 2.291

Pat_Stiffl4- consultation 4

A 4.55 1 8 2.35

B 2.6 1 6 1.392

Table F. 49 POSAS Patient scale stiffness test for normality Shapiro Wilk test

Group Group

Sig.

Pat_Stiff1 Patient scale -Stiffness- consultation1 A .547

B .536

Pat_Stiff2 Patient scale -Stiffness- consultation 2 A .089

B .227

Pat_Stiff3 Patient scale -Stiffness- consultation 3 A .223

B .021

Pat_Stiff4 Patient scale -Stiffness- consultation 4 A .109

B .036

Table F. 50 POSAS Patient scale stiffness Mann Whitney U test

Pat_Stiff1

Patient

scale

Pat_Stiff2

Patient

scale

Pat_Stiff3

Patient

scale

Pat_Stiff4

Patient

scale

Asymp.

Sig. (2-

tailed)

.601 .268 .184 .008

Table F. 51 POSAS Patient scale stiffness Friedman test

A N 20

Chi-Square 11.197

df 3

Asymp. Sig. .011

B N 20

Chi-Square 30.054

df 3

Asymp. Sig. .000

108

Table F. 52 POSAS Patient scale stiffness Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.038b -2.447

b -2.553

b

Asymp.

Sig. (2-

tailed)

.042 .014 .011

B Z -2.521b -2.588

b -3.526

b

Asymp.

Sig. (2-

tailed)

.012 .010 .000

2.5 Thickness

Table F. 53 POSAS Patient scale thickness mean values

Pat_Thick1- consultation1

Mean Min Max Std.Dev

A 6.14 2 10 2.532

B 6.75 2 10 2.511

Pat_Thick2 -consultation 2

A 5.2 1 8 2.375

B 4.7 1 9 2.179

Pat_Thick3consultation 3

A 4.65 1 8 2.412

B 4.2 1 10 2.167

Pat_Thick4- consultation 4

A 4.85 1 9 2.56

B 2.7 1 6 1.418

Table F. 54 POSAS Patient scale thickness test for normality Shapiro Wilk

Group Group

Sig.

Pat_Thick1 Patient scale -Thickness-

consultation1

A .170

B .165

Pat_Thick2 Patient scale -Thickness-

consultation 2

A .034

B .839

Pat_Thick3 Patient scale -Thickness-

consultation 3

A .046

B .157

Pat_Thick4 Patient scale -Thickness-

consultation 4

A .192

B .028

109

Table F. 55 POSAS Patient scale thickness Mann Whitney U test

Pat_Thick1

Patient

scale

Pat_Thick2

Patient

scale

Pat_Thick3

Patient

scale

Pat_Thick4

Patient

scale

Asymp.

Sig. (2-

tailed)

.445 .405 .452 .008

Table F. 56 POSAS Patient scale thickness Friedman

A N 20

Chi-Square 16.921

df 3

Asymp. Sig. .001

B N 20

Chi-Square 33.468

df 3

Asymp. Sig. .000

Table F. 57 POSAS Patient scale thickness Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.527b -3.034

b -2.700

b

Asymp.

Sig. (2-

tailed)

.012 .002 .007

B Z -3.194b -3.010

b -3.779

b

Asymp.

Sig. (2-

tailed)

.001 .003 .000

2.6 Regularity

Table F. 58 POSAS Patient scale regularity mean values

Pat_Reg1- consultation1

Mean Min Max Std.Dev

A 6.05 1 10 2.8201

B 6.5 1 10 2.743

Pat_Reg2 -consultation 2

A 5.05 1 8 2.502

B 4.7 1 9 2.452

Pat_Reg3consultation 3

A 4.45 1 8 2.373

B 4.4 1 9 2.088

Pat_Reg4- consultation 4

A 4.5 1 9 2.503

B 3.15 1 8 2.084

110

Table F. 59 POSAS Patient scale regularity test for normality Shapiro Wilk

Group Group

Sig.

Pat_Reg1 Patient scale -Regularity-

consultation1

A .233

B .124

Pat_Reg2 Patient scale -Regularity-

consultation 2

A .034

B .256

Pat_Reg3 Patient scale -Regularity-

consultation 3

A .114

B .492

Pat_Reg4 Patient scale -Regularity-

consultation 4

A .328

B .006

Table F. 60 POSAS Patient scale regularity Mann Whitney U test

Pat_Reg1

Patient

scale

Pat_Reg2

Patient

scale

Pat_Reg3

Patient

scale

Pat_Reg4

Patient

scale

Asymp.

Sig. (2-

tailed) .575 .604 .913 .080

Table F. 61 POSAS Patient scale Regularity

A N 20

Chi-Square 21.152

df 3

Asymp. Sig. .000

B N 20

Chi-Square 28.724

df 3

Asymp. Sig. .000

Table F. 62 POSAS Patient scale regularity Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.193b -3.143

b -3.245

b

Asymp.

Sig. (2-

tailed)

.028 .002 .001

B Z -2.811b -2.931

b -3.503

b

Asymp.

Sig. (2-

tailed)

.005 .003 .000

111

2.7 Overall opinion

Table F. 63 POSAS Patient scale overall opinion mean values

Pat_Over1- consultation1

Mean Min Max Std.Dev

A 5.95 2 10 2.236

B 7.05 2 10 2.305

Pat_Over2 -consultation 2

A 4.85 1 8 1.927

B 5.6 2 10 2.088

Pat_Over3consultation 3

A 4.5 2 8 2.065

B 4.1 2 9 2.15

Pat_Over4- consultation 4

A 4.5 1 8 1.96

B 3.2 1 7 1.765

Table F. 64 POSAS Patient scale overall opinion test for normality Shapiro Wilk

Group Group

Sig.

Pat_Tot1 Patient scale -Total- consultation1 A .225

B .130

Pat_Tot2 Patient scale -Total- consultation 2 A .219

B .809

Pat_Tot3 Patient scale -Total- consultation 3 A .262

B .455

Pat_Tot4 Patient scale -Total- consultation 4 A .487

B .008

Table F. 65 POSAS Patient scale overall opinion Mann Whitney U test

Pat_Over1

Patient

scale

Pat_Over2

Patient

scale

Pat_Over3

Patient

scale

Pat_Over4

Patient

scale

Asymp.

Sig. (2-

tailed)

.168 .292 .495 .036

Table F. 66 POSAS Patient scale overall opinion Friedman test

A N 20

Chi-Square 24.902

df 3

Asymp. Sig. .000

B N 20

Chi-Square 45.568

df 3

Asymp. Sig. .000

112

Table F. 67 POSAS Patient scale overall opinion Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.882b -3.331

b -3.461

b

Asymp.

Sig. (2-

tailed)

.004 .001 .001

B Z -2.908b -3.643

b -3.840

b

Asymp.

Sig. (2-

tailed)

.004 .000 .000

3. Digimizer®

3.1 Area of scar

Table F. 68 Digimizer area of scar mean values

Dig1- consultation1

Mean Min Max Std.Dev

A 4.227 1.138 7.773 1.812

B 5.667 2.036 17.474 3.690

Dig2 -consultation 2

A 3.274 0.780 9.832 2.126

B 5.818 1.814 37.968 8.3899

Dig3consultation 3

A 2.644 0.350 6.189 1.519

B 3.633 1.331 11.539 2.453

Dig4- consultation 4

A 2.331 0.166 6.855 1.730

B 2.922 0.982 8.453 2.040

Table F. 69 Digimizer test for normality Shapiro Wilk

Group Group

Sig.

Dig_consultation1 A .873

B .001

Dig_consultation 2 A .010

B .000

Dig_Total- consultation 3 A .344

B .001

Dig_Total- consultation 4 A .012

B .000

113

Table F. 70 Digimizer area of scar Mann Whitney U test

Dig_1 Dig_2 Dig_3 Dig_4

Asymp.

Sig. (2-

tailed)

.257 .402 .185 .229

Table F. 71 Digimizer area of scar Friedman test

A N 20

Chi-Square 29.040

df 3

Asymp. Sig. .000

B N 20

Chi-Square 39.420

df 3

Asymp. Sig. .000

Table F. 72 Digimizer area of scar Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -2.501b -3.845

b -3.808

b

Asymp.

Sig. (2-

tailed)

.012 .000 .000

B Z -2.240b -3.883

b -3.920

b

Asymp.

Sig. (2-

tailed)

.025 .000 .000

3.2 Width of scar

Table F. 73 Digimizer width mean values

Dig1- consultation1

Mean Min Max Std.Dev

A 2.081 0.704 3.749 0.916

B 3.474 0.601 10.378 2.661

Dig2 -consultation 2

A 2.385 0.529 9.121 1.845

B 3.139 0.568 13.842 3.184

Dig3consultation 3

A 2.063 0.509 8.584 1.762

B 2.602 0.729 7.480 1.911

Dig4- consultation 4

A 2.190 0.455 12.693 2.642

B 2.863 0.459 8.490 2.422

114

Table F. 74 Digimizer width of scar test of normality Shapiro Wilk

Group Group

Sig.

Dig_consultation1 A .056

B .004

Dig_consultation 2 A .000

B .000

Dig_Total- consultation 3 A .000

B .003

Dig_Total- consultation 4 A .000

B .000

Table F. 75 Digimizer width of scar Mann Whitney U test

Dig_1 Dig_2 Dig_3 Dig_4

Asymp.

Sig. (2-

tailed)

.099 .449 .279 .168

Table F. 76 Digimizer width Friedman test

A N 20

Chi-Square 9.960

df 3

Asymp. Sig. .019

B N 20

Chi-Square 5.940

df 3

Asymp. Sig. .115

Table F. 77 Digimizer width Wilcoxon signed ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -.411b -2.277

c -2.091

c

Asymp.

Sig. (2-

tailed)

.681 .023 .037

B Z -1.381c -2.670

c -1.120

c

Asymp.

Sig. (2-

tailed)

.167 .008 .263

115

3.3 Length of scar

Table F. 78 Digimizer length mean values

Dig1- consultation1

Mean Min Max Std.Dev

A 11.875 6.785

16.655 2.556

B 13.622 8.766 22.222 4.139

Dig2 -consultation 2

A 10.820 0.834 18.906 3.816

B 13.290 7.836 38.719 6.756

Dig3consultation 3

A 10.253 2.218 13.158 2.352

B 12.319 8.696 22.313 3.478

Dig4- consultation 4

A 9.833 2.049 13.140 2.715

B 12.153 8.067

23.714 4.187

Table F. 79 Digimizer Length test for normality Shapiro Wilk

Group Group

Sig.

Dig_consultation1 A .252

B .006

Dig_consultation 2 A .035

B .000

Dig_consultation 3 A .001

B .001

Dig_ consultation 4 A .037

B .001

Table F. 80 Digimizer length Mann Whitney U test

Dig_1 Dig_2 Dig_3 Dig_4

Asymp.

Sig. (2-

tailed)

.279 .245 .123 .256

116

Table F. 81 Digimizer length Friedman test

A N 20

Chi-Square 9.540

df 3

Asymp. Sig. .023

B N 20

Chi-Square 12.540

df 3

Asymp. Sig. .006

Table F. 82 Digimizer length Wilcoxon Signed Ranks test

Group Group W0-W4 W0-W8 W0-W12

A Z -1.195b -2.912

b -2.651

b

Asymp.

Sig. (2-

tailed)

.232 .004 .008

B Z -1.717b -2.725

b -2.875

b

Asymp.

Sig. (2-

tailed)

.086 .006 .004