Assessing the Effectiveness of Protescal In Preventing Post Caesarean Section Hypertrophic Scar and Keloid
Phase: PHASE2
Conditions: Caesarean Wound, Hypertrophic Surgical Scar, Keloid Scar Following Surgery
Sponsor: Universiti Kebangsaan Malaysia Medical Centre

 
 
 
TITLE: 
A 
STUDY 
TRIAL 
ON 
PROTESCAL 
IN 
PREVENTING POST CAESAREAN SECTION 
HYPERTROPHIC SCAR AND KELOID  
 
 
 
 
PRINCIPAL INVESTIGATOR :  DR ANIZAH ALI 
CO-RESEARCHER : DR. NOR AZILA MOHD NAFIAH 
 
RESEARCH  CODE : FF-2017-170 
 
DATE : 26/4/2017 
 
 
 
 
 
 
 

Content Page 
1.0 Introduction  
2.0 Objectives of the study 
2.1 General objective 
2.2 Specific objectives 
3.0 Outcomes 
3.1 Primary outcome 
3.2 Secondary outcome 
4.0 Methodology  
4.1 Study design  
4.2 Place of study  
4.3 Study population  
4.4 Duration of study  
4.5 Inclusion Criteria 
4.6 Exclusion Criteria 
4.7 Randomization  
4.8 Data Collection and statistical analysis  
4.9 Sample size calculation 
4.10 Study flow chart 
4.11 Study Protocol 
5.0 References  
 
 
 
 
 
 

1.0  INTRODUCTION 
 
Every year several million women worldwide acquire an abdominal scar as a result of 
caesarean delivery. Obstetricians often consider skin closure after a caesarean section as a 
trivial aspect of the procedure, because the skin scar is deemed the normal and inevitable price 
we pay foe tissue repair. Moreover, the anatomical location of caesarean scars, which hide 
easily beneath underwear, and the generally held belief that all transverse suprapubic incision 
heal about equally well further contribute to the underestimation by practitioners of the 
importance of scar appearance to patients. 
 
Young women place supreme importance on cosmetic outcomes, but scarring can also affect 
patient in term of symptoms ( pain, tenderness, and itching ) and has the potential to have a 
negative impact overall quality of life, being a source of considerable distress, loss of self 
esteem and stigmatization. 
 
The final appearance and the function of the healed skin is dependent on patient and wound 
factors, which are often outside the control of a surgeon, and technical factors, which are 
completely within the control of the surgeon and include closure material and technique of skin 
apposition. 
 
There were few study trial done with the aims of preventing hyperthropic scar formation 
following caesarean section. Antonella Cromi et al ( obstet Gynaecol 2010, 203: 36.el-8 ) did 
a randomized trial on 123 patient to compare scar quality associated with different types of 
wound closure method after caesarean section. The result showed that the were no difference 
in scar quality in either staples or 3 different types of subcurticular sutures. 
 
Atkinson et al ( 2005 American Society of plastic surgeon) performed a randomized controlled 
trial involving 70 patient to determine the efficacy of paper tape in preventing hyperthrophic 
scar formation in surgical incisions  that traverse Langer's skin tension lines. 
Result suggest that tension acting on a scar is the trigger for hyperthrophic scarring, and paper 
tape is likely to be an effective modality for prevention of  hypertrophic scarring through its 
ability to eliminate scar tension. 
 
The aims of this study is to prevent hypertrophic scar and keloid formation post caesarean 
section using PROTESCAL adhesion barrier.  PROTESCAL, a combination of hyaluronic 
acid, methylcellulose, and alginate  was  manufactured by Korean pharmaceutical companies 
and  became available since 2012. PROTESCAL was developed to prevent complications such 
as ileus, pain and infertility due  to postoperative adhesion. 
 
 Hyaluronic acid is a natural polymer of disaccharides, one of the components of the 
extracellular matrix. It is present in the skin, cartilage, bone and brain. Because of its 
biocompatibility, moisture capacity, and viscoelasticity, hyaluronic acid has been used as 

artificial tears in drug delivery systems, and tissue restoration materials, and it plays a role in 
inflammation, granulation and re-epithelization for wound healing.  It has proved valuable in 
neurosurgery and dermatology because hyaluronic acid and degradation products can modulate 
wound healing. There is wide scientific evidence on the positive role of hyaluronic acid in 
tissue regeneration and wound healing.  
Carboxymethylcellulose is a high molecular weight polysaccharide that has a concentration 
and volume that are inversely correlated with its antiadhesive agent. The combination of 
carboxymethylcellulose and hyaluronic acid has had a preventive effect on the formation of 
adhesion in  various surgical fields. 
Alginate has been used as a wound dressing agent, its calcium or sodium form has hemostatic 
and antimicrobial effects, and it has been shown to prevent adhesion formation in animal 
studies. 
With the combination of hyluronic acid, methylcellulose and alginate, which already proven 
scientifically benefit in wound healing, we aims to prevent the hypertrophic scar and keloid 
formation following caesarean section by applying PROTESCAL in subcutaneous layer prior 
to skin closure. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2.0  OBJECTIVE OF THE STUDY 
2.1 General Objective 
To evaluate the effectiveness of Protescal in preventing post caesarean section hypertrophic 
scar and keloid and pelvic adhesion. 
 
2.2 Specific Objectives 
To determine the effectiveness of Protescal in preventing hypertrophic scar and keloid 
compared to control group. 
To determine the effectiveness of Protescal in preventing pelvic adhesion 
 
3.0 OUTCOMES 
3.1 Primary 
To assess the outcome of healing of the external scar  
3.2 Secondary 
To look for adhesion formed during next caesarean section 
         
4.0 RESEARCH METHODOLOGY  
4.1 Study design 
Prospective, randomized controlled clinical trial 
 
4.2 Place of study 
Obstetric ward and maternity operation theatre of  Department of Obstetrics and Gynaecology, 
Universiti Kebangsaan Malaysia Medical Centre (UKMMC). 
 
 
4.3 Study Population 

All women undergoing elective caesarean section, without any history of previous abdominal 
surgery; who planned for further pregnancy and consented to participate in this study. 
 
4.4  Duration of study 
6 months duration; from April 2017 to October 2017  
 
4.5  Inclusion Criteria 
Pregnant women without any history of previous abdominal surgery 
Plan for elective caesarean section for this current pregnancy section  
Transverse suprapubic scar 
 
4.6  Exclusion Criteria 
Patient who are allergic to protescal  
Patient with previous abdominal surgery 
Patient with surgery complication 
 
4.7  Randomization 
The randomization sequence, either to Protescal group or control group, was generated by using 
a computer randomization program; in the maternity operation theatre or antenatal clinic . 
 
4.8 Data Collection And Statistical Analysis  
SPSS (Statistical Package of Social Science) version 20.0 will be employed proportional data 
will be compared with chi square. The Fisher exact test will be chosen if the expected size of  
any cell of the contingency table is less than 5. Continuous data will be compared using the  
Wilcoxon rank-sum test. Multiple logistic regressions will be use to model the relationship  
between group assignment, controlling for possible confounders. P<0.05 will be considered  
significant. 
 

4.9 Sample Size Calculation  
• 
The sample size was calculated based on computerized generated formula,  Cohen’s 
(1988) formula.  
• 
Effect size calculator for T Test 
• 
For the independent samples T-test, cohen’s d id determined by calculating the mean 
difference between two groups, and then dividing the result by pooled standard 
deviation 
 
 
 cohen’s d = M2 – M1/ SD pooled 
 
        SD pooled =√ ( (SD12 + SD22) / 2) 
• 
Using effect size f = 0.60, alpha = 0.05 and power = 0.80, the appropriate number of 
participants was calculated as 45 in each group.  
 
 
Cohen’s Sample Size Table 
D 
Power 0.10 
0.20 
0.30 
0.40 
0.50 
0.60 
0.70 
0.80 
1.0 
1.20 
1.40 
0.25 
332 
84 
38 
22 
14 
10 
8 
6 
5 
4 
3 
0.50 
769 
193 
86 
49 
32 
22 
17 
13 
9 
7 
5 
0.60 
981 
246 
110 
62 
40 
28 
21 
16 
11 
8 
6 
2/3 
1144 
287 
128 
73 
47 
33 
24 
19 
12 
9 
7 
0.70 
1235 
310 
138 
78 
50 
35 
26 
20 
13 
10 
7 
0.75 
1389 
348 
155 
88 
57 
40 
29 
23 
15 
11 
8 
0.80 
1571 
393 
175 
99 
64 
45 
33 
26 
17 
12 
9 
0.85 
1797 
450 
201 
113 
73 
51 
38 
29 
19 
14 
10 
0.90 
2102 
526 
234 
132 
85 
59 
44 
34 
22 
16 
12 
0.95 
2600 
651 
290 
163 
105 
73 
54 
42 
37 
19 
14 
0.99 
3675 
920 
409 
231 
148 
103 
76 
58 
38 
27 
20 
 
 
 
 
 
 
4.10 Study Flow Chart 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protescal applied at uterine 
suture site and in subcutaneous 
tissue layer prior to skin 
closure 
No protescal applied at uterine 
suture site and in subcutaneous 
tissue layer prior to skin closure 
All women planned for elective caesarean section 
Assess patient eligibility fulfill inclusion and exclusion criteria 
Patient suitable for recruitment and consented 
Recruited 
Present for delivery via caesarean section 
Caesarean section performed as 
usual 
Control group 
Transverse suprapubic skin 
incision made 
Randomization process 
Study group 
Transverse suprapubic skin 
incision made 
Caesarean section performed as 
usual 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.11 Study Protocol   
Skin closed subcurticularly 
Skin closed subcurticularly 
Day 10 post caesarean section : external scar assess using REEDA scale 
3 months post caesarean section : external scar assess using Vancouver scar 
scale 

After delivering the baby through caesarean section, uterine muscle is closed in 2 layers with 
braided absorbable suture, polyglactin 910 (vicryl no 1). 
After haemostasis secure, 4 ml Protescal gel apply at the uterine suture site. 
Peritoneal layer close using braided absorbable suture, polyglactin 910 (vicryl no 1). 
 Rectus sheath suture using braided absorbable suture, polyglactin 910 (vicryl no 1). 
Subcutaneous tissue close interruptedly using braided absorbable suture,  polyglactin 910 
(vicryl no 1). 
1 ml Protescal gel apply in subcutaneous tissue prior to skin closure. 
Skin close with subcuticular method using braided absorbable suture, polyglactin 910 (vicryl 
3-0). 
Wound healing  assess on 10th day post caesarean section using REEDA scale, which had 
criteria including redness, edema, ecchymosis, discharge and approximation. 
On 3rd month, the degree of scarring assess using the Vancouver scar scale including 
pigmentation, height, pliability and vascularity. 
 
 
 
 
 
 
 
 
 
 
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