Optimizing Early Cesarean Scar Healing: A Randomized Controlled Trial of Hydrophilic Methacrylate Gel Versus Beta-Sitosterol Ointment
Phase: NA
Conditions: Cesarean Section Scar, Wound Healing
Sponsor: Hamad Medical Corporation

HMC RESEARCH 
PROTOCOL 
1 
09/04/2026 2:14 PM 
 
 
Study Title: 
“Comparing the effectiveness of Hydrophilic Methacrylate Gel (Hemagel) and 
Beta Sitosterol Ointment in the Healing of Episiotomy and Cesarean Section 
Scars: A Randomized Controlled Trial” 
NCT Number:  
 
To be assigned after registration 
Note : 
This protocol describes two cohorts (cesarean section and episiotomy).  
The results submitted with this registration are for the cesarean section  
cohort only. Results for the episiotomy cohort will be submitted separately  
if applicable. 
 
Principal Investigator: 
Yehia El Khawly – Pharmacy department -AL Wakra Hospital 
Sponsor 
 
Hamad Medical Corporation 
IRB Protocol Number  
 
MRC-01-23-518 
Document Date 
 
Apr, 9, 2026 
 
 
Contents 
1. 
Synopsis 2 
2. 
Abbreviations and Acronyms ............................................................................................................... 3 
3. 
Introduction / Background .................................................................................................................... 3 
4. 
Objectives ............................................................................................................................................. 4 
5. 
Indicate if this is a retrospective data review ........................................................................................ 5 
6. 
Study Methodology ............................................................................................................................... 4 
7. 
Study Population and Study Setting/ Location ..................................................................................... 5 
8. 
Study procedures ................................................................................................................................... 5 
Study Duration and Timelines .................................................................................................. 6 
Informed Consent ..................................................................................................................... 8 
Risk ........................................................................................................................................... 8 

HMC RESEARCH 
PROTOCOL 
2 
09/04/2026 2:14 PM 
 
 
Bio-Specimens & Sample Collection ....................................................................................... 8 
Outcomes .................................................................................................................................. 9 
Data Collection & Confidentiality ............................................................................................ 9 
Subject Withdrawal/ Withdrawal of Consent ......................................................................... 10 
9. 
Statistical Consideration and Data Analysis ....................................................................................... 11 
10. 
Adverse Event Reporting ................................................................................................. 12 
11. 
Ethical Consideration ....................................................................................................... 13 
12. 
Sponsor, Funding & Collaborator Information ............................................................... 13 
13. 
Dissemination of Results and Publication policy ............................................................ 13 
14. 
References ....................................................................................................................... 14 
15. 
Appendices ...................................................................................................................... 14 

HMC RESEARCH 
PROTOCOL 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
1. Synopsis 
This RCT aims to assess the effectiveness of HM Gel (Hydrophilic Methacrylate 
Gel)and BS (Beta Sitosterol Ointment) in promoting the healing process of episiotomy andCS 
(cesarean section scars). 
 
Episiotomy and cesarean section are common surgical procedures in obstetrics and 
gynecology, and scar healing is an important aspect of postoperative recovery. However, there 
is a lack of evidence comparing the effectiveness of topical treatments specifically for 
these types of scars. This study seeks to address this research gap by evaluating the 
effectiveness of Hydrophilic Methacrylate Gel and Beta Sitosterol Ointment in scar healing 
after episiotomy and cesarean section procedures. 
 
The trial will employ a prospective, randomized controlled design. Adult females who 
have recently undergone episiotomy or cesarean section procedures will be recruited as 
participants, and informed consent will be obtained from each participant. 
 
Participants will be randomly assigned to one of two groups: an experimental group receiving 
Hydrophilic Methacrylate Gel and a control group receiving Beta Sitosterol Ointment. The 
application of the respective treatments will follow established protocols. 
 
Data collection will involve objective measures and participant-reported outcomes. 
Parameters such as wound healing progress, scar appearance, pain levels, and patient 
satisfaction will be assessed at predetermined intervals using standardized assessment tools 
and scoring systems. 
 
Statistical analysis will be conducted to compare the primary and secondary outcomes 
between the two treatment groups. Appropriate statistical tests, such as t-tests or chi- square 
tests, will be employed to analyze the data. 
 
The study will be conducted in adherence to HMC ethical guidelines, ensuring participant 
safety, privacy, and confidentiality. 
 
The findings of this study will provide valuable insights into the effectiveness of Hydrophilic 
Methacrylate Gel and Beta Sitosterol Ointment in promoting the healing of episiotomy and 
cesarean section scars. The results may guide healthcare professionals in selecting optimal 
topical treatments for scar management, ultimately improving patient outcomes and 
satisfaction in the context of these surgical procedures. 
 
3 

HMC RESEARCH 
PROTOCOL 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
 
2. Abbreviations and Acronyms 
RCT: Randomized Controlled Trial 
HM Gel: Hydrophilic Methacrylate Gel 
BS Ointment: Beta Sitosterol Ointment 
CS: Cesarean Section 
HMC: Hamad Medical Corporation 
3. Introduction / Background 
Episiotomy and cesarean section (CS) are common surgical procedures in obstetrics and 
gynecology, often performed to safeguard the well-being of both mothers and newborns (1). 
Adequate wound healing and effective scar management are vital components ofpostoperative care, 
profoundly influencing patient recovery, comfort, and long-termquality of life (2). However, 
despite the significance of these aspects, the current body of literature presents a noticeable gap in 
real-world evidence regarding the effectiveness of topical treatments specifically tailored for post-
episiotomy and CS scars. 
 
The absence of well-established treatment protocols, coupled with the limited researchin this 
area, presents significant challenges for healthcare professionals tasked with selecting the 
most suitable interventions for scar management. Current standard practices typically involve the 
use of emollients, moisturizers, and silicone-based products (3). However, the empirical evidence 
supporting their efficacy in promoting wound healing and enhancing patient satisfaction remains 
inconclusive (4, 5). 
In the specific context of Al-Wakra Hospital, we conduct an average of approximately 
350 deliveries each month, which includes both cesarean sections and normal deliveries with 
episiotomy procedures. This significant volume of procedures highlights the relevance and 
importance of investigating the most effective scar management interventions. 
In our standard clinical practice at Al-Wakra Hospital, emollient, moisturizer such as betasitosterol 
is commonly used for scar management. 
 
The local healthcare system in Qatar and Al-Wakra Hospital is committed to providingthe highest 
standard of care to its diverse patient population. Given the substantial number of patients 
undergoing episiotomy and cesarean section procedures, optimizing scar management is 
imperative to improve patient outcomes and enhance overall healthcare quality. 
The present research seeks to bridge this knowledge gap by conducting a rigorous clinical 
trial to evaluate the potential benefits of novel scar management interventionsfor post- episiotomy 
and CS scars. In particular, this study focuses on the effectiveness of Hemagel Ointment, a topical 
hydrophilic methacrylate gel that has demonstrated promise in wound healing and scar management 
across various clinical settings (6). Hemagel's hydrophilic nature allows it to create a moist 
wound environment, which aligns with established principles of wound healing (7). 

HMC RESEARCH 
PROTOCOL 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
 
Additionally, its mechanism of action involves the formation of a protective barrier over the wound 
site, potentiallyreducing infection risk and facilitating a controlled healing process (8). 
While some studies have explored the application of Hemagel Ointment in wound healing, its 
specific effects on post-episiotomy and CS scars remain relatively uncharted territory. 
Consequently, there exists a compelling need to conduct well-designed clinical trials that rigorously 
assess Hemagel Ointment's efficacy and safety in the context ofthese surgical procedures. 
 
Therefore, the aim of this study is to evaluate the effectiveness and safety of Hemagel Ointment 
in post-episiotomy and cesarean section scar care through a randomized clinical trial. This 
trial will provide comprehensive evidence regarding the effectivenessof Hemagel Ointment in 
promoting wound healing, alleviating pain, improving scar appearance, and enhancing patient 
satisfaction in these specific contexts. 
 
By conducting a rigorous randomized clinical trial, we seek to generate high-quality data that 
will inform clinical practice and guide healthcare professionals in selecting optimal interventions 
for scar management in post-episiotomy and cesarean section cases. This research will contribute 
to the existing body of knowledge in scar care and providevaluable insights for healthcare 
professionals, ultimately improving patient outcomes. 
 
The results of this study have the potential to facilitate evidence-based decision-making, facilitate 
personalized patient care, and potentially reduce the burden of complicationsassociated with post-
episiotomy and cesarean section scars. Furthermore, the findings will contribute to advancing the 
field of scar management and may pave the way forfuture research and the development of targeted 
interventions. 
 
4. 
Objectives 
1- The primary objective of this trial is to evaluate the effectiveness of Hemagel Ointment in 
promoting wound healing and reducing complications among patients who have undergone 
episiotomy or cesarean section procedures. The assessment of wound healing will be conducted 
using a validated assessment tool, which is included as an attachment. 
 
2- The secondary objectives of this study involve assessing the impact of Hemagel Ointment on pain 
management, scar appearance, and patient satisfaction. To measure pain levels, standardized pain 
scales will be utilized, allowing for a 
 
 
4 

HMC RESEARCH 
PROTOCOL 
6 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
comparison of the effectiveness of Hemagel Ointment in alleviating pain compared to 
the control group. Furthermore, scar appearance will be evaluatedusing the Patient and 
Observer Scar Assessment Scale (POSAS), which is a validated tool designed to assess 
cosmetic outcomes. Patient satisfaction will be assessed through questionnaires, which are 
provided as an attachment. 
Additionally, standardized pain scales will be employed to assess pain levels, and the 
attached scale provides further details on this measurement. 
 
5. 
Indicate if this is a retrospective data review 
• 
 Prospective study 
Provide the date range of the chart review: RCT 
 
6. 
Study Methodology 
The proposed study is a prospective, randomized controlled trial (RCT) that aims tocompare 
the effectiveness of two topical treatments, HM Gel (Hydrophilic Methacrylate Gel) and BS 
Ointment (Beta Sitosterol Ointment), in promoting the healing process of episiotomy and cesarean 
section scars. The study will include two groups: an experimental group receiving HM Gel and 
a control group receiving BS Ointment. 
 
Sample size calculation or justification of numbers: A priori sample size calculationwill be 
conducted to determine the required number of participants for adequate statistical power. 
This calculation will consider factors such as the expected effect size, desired level of significance, 
power of the study, and anticipated dropout rate. We aim to recruit enough participants to ensure 
the statistical validity and generalizability of the study results. 
The sample size for this study was determined based on the desired level of statistical power 
(80%) and the significance level (0.05). Since no prior estimates of effect size were available, 
a moderate effect size was assumed. Using a two-sample t-test, the sample size per group was 
calculated to be 53 participants in patients with cesarean section. Considering rounding up to the 
nearest whole number, a total sample size of 
106 participants was determined for the 2 groups of cesarean section, and the same number for 
patients (53) with episiotomy, a total of 106 participants was determined for the 2 groups of 
vaginal delivery with episiotomy.  This sample size calculation ensuresthat the study will 
have sufficient power to detect meaningful differences in pain levels and wound healing outcomes. 
Dropout Rate: 
The anticipated dropout rate is indeed an important consideration in sample size determination. 
We recognize  the potential  for participant  attrition during  the course  of our study. To 

HMC RESEARCH 
PROTOCOL 
7 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
address this concern and to ensure the robustness of our findings, we have factored in an anticipated 
dropout rate of 10% in our sample size calculation. While this rate is conservative and aligned 
with similar clinical trials, we understand the importanceof minimizing the impact of dropout on our 
study's outcomes. 
Sample Size Adjustment: 
To further enhance the reliability of our results and address the concern regarding sample 
size, we have considered increasing the sample size slightly. By recruiting approximately 60 
patients per group, we aim to provide against dropout-related issuesand enhance the generalizability 
of our findings. This adjustment allows for a more robust study design without compromising 
the practicality of recruitment within our study timeline and available resources. 
 
Details of the interventions (not procedures) involved in the research: 
The study involves the application of two topical treatments, HM Gel and BS Ointment,to 
the respective treatment groups. The application of these treatments will follow established 
protocols. The study does not involve any invasive procedures. 
The administration of the assigned treatments will be administered in routine clinicalpractice 
following the surgical procedure, either episiotomy or cesarean section, and continue for a period 
of two weeks. During this period, the participants will be instructed on the proper application of 
the treatments. The application frequency and dosage willbe as follows: 
• 
Hydrophilic Methacrylate Gel (HM Gel): Participants in the experimental groupwill be 
instructed to apply HM Gel to the surgical site two times a day, in the morning and evening, 
for the duration of the two-week treatment period. 
• 
Beta Sitosterol Ointment (BSO): Participants in the control group will be instructed to 
apply BSO to the surgical site two times a day, in the morning and evening,also for the duration 
of the two-week treatment period. 
• 
The application process will be explained to each participant, emphasizing the importance 
of consistent and thorough application. Adherence to the treatment regimenwill be monitored 
through regular follow-up visits. These follow-up visits will coincide with the baseline assessment, 
occurring at recruitment, and subsequent visits at Day 5and Day 12 postpartum. The 
administration of the assigned treatments will commence immediately following the surgical 
procedure, either episiotomy or cesarean section, and continue for a period of two weeks. 
During this period, the participants will be instructed on the proper application of the treatments. 
The application frequency and dosage will be as follows: 
• 
Hydrophilic Methacrylate Gel (HM Gel): Participants in the experimental groupwill be 
instructed to apply HM Gel to the surgical site two times a day, in the morning and evening, 
for the duration of the two-week treatment period. 

HMC RESEARCH 
PROTOCOL 
8 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
• 
Beta Sitosterol Ointment (BSO): Participants in the control group will be instructed to 
apply BSO to the surgical site two times a day, in the morning and evening,also for the duration 
of the two-week treatment period. 
• 
The application process will be explained to each participant, emphasizing the importance 
of consistent and thorough application. Adherence to the treatment regimenwill be monitored 
through regular follow-up visits. These follow-up visits will coincide with the baseline assessment, 
occurring at recruitment, and subsequent visits at Day 5and Day 12 postpartum. 
• 
Phone Call Reminders by a trained staff to assess adherence of application. (Script is 
added in documentation in ABHATH) 
Follow-Up Phone Calls: 
Phone call reminders will be made by trained staff to assess treatment adherence. Specific 
timepoints for planned follow-up phone calls are Day 3 and Day 7. 
 
These follow-up calls will serve to reinforce proper application, address any concerns,and ensure 
consistent adherence to the treatment regimen. The detailed script in the ABHATH documentation 
provides guidance for the phone call reminders. 
Data/samples (bio-specimens/information) collected at each time point and why: 
Data collection will involve both objective measures and participant-reported outcomes. The 
data to be collected at each time point include: 
 
• Wound healing progress: This objective measure will assess the healing processof the 
scars over time. 
• Scar appearance: This will be evaluated using the Patient and Observer Scar Assessment 
Scale (POSAS), a validated tool designed to assess cosmetic outcomes. 
• Pain levels: Standardized pain scales will be employed to assess pain levels, comparing 
the effectiveness of the treatments in alleviating pain. 
• Patient satisfaction: Questionnaires will be used to gather information on patient satisfaction 
with the treatment outcomes. 
• These data will provide valuable insights into the assessment of the effectiveness of the 
treatments and their impact on wound healing, scar appearance, painmanagement, and 
patient satisfaction. 
Risks to participants in the proposed research and anticipated benefits to clinical/health 
outcome: 
As described, the proposed research involves the use of topical treatments (HM Geland 
BS Ointment) for wound healing and scar management. Both treatments are generally 
considered safe, and no invasive procedures are involved in the study. 

HMC RESEARCH 
PROTOCOL 
9 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
The anticipated benefits to participants include improved wound healing and scar appearance, 
reduced pain levels, and potentially enhanced patient satisfaction with the treatment outcomes. 
By comparing the two treatments, the study aims to provide evidence-based recommendations 
for scar management after episiotomy and cesarean section procedures, which may improve 
patient care and outcomes in these surgical contexts. The risks to participants are minimal, 
and the potential benefits to clinical and health outcomes make the research reasonably 
worthwhile. 
 
7. Study Population and Study Setting/ Location 
This study will be a prospective, randomized, controlled clinical trial. Participants will be 
randomly assigned to either an experimental group receiving HydrophilicMethacrylate Gel 
(HM Gel) or a control group receiving Beta Sitosterol Ointment(BS Ointment). The 
randomization process will utilize a stratified randomization method based on age and BMI 
to ensure balanced representation of different age groups and BMI categories within each 
treatment group. 
Stratification: 
In our study, we will indeed have two distinct groups of patients: those who have undergone 
episiotomy and those who have undergone cesarean section. We recognize that the type 
of surgery is a potentially important factor that should be considered in the randomization 
process to ensure balanced representation of both surgical groups in each treatment arm. To 
address this concern, we will implement a stratified randomization approach that accounts 
for the type of surgery as a stratification factor. Specifically, during the randomization 
process, participants will be stratified into two groups: the episiotomy group and the cesarean 
section group. Within each of these strata, randomization will be performed independently 
to allocate participants to either the experimental group receiving Hydrophilic Methacrylate 
Gel (HM Gel) or the control group receiving Beta Sitosterol Ointment (BS Ointment). In 
our final study report, we will provide a detailed description ofthe randomization process, 
including how participants were allocated to treatmentgroups within each stratum. 
 
Blinding: 
We will be blinding the tube ointments to ensure impartiality in the assessment of efficacy 
between the two treatments. This adjustment will enable us to minimize potential biases and 
ensure the integrity of our results. 
The ointment tubes will be packaged in identical outer packaging, such as opaque boxes, to 
conceal any distinguishing features. 
This approach will ensure that the participants nor the assessors of wound know which 

HMC RESEARCH 
PROTOCOL 
10 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
ointment is being used. 
 
In addition, to minimize bias during data analysis, the data analysts will be blinded to the 
treatment allocation until the analysis is completed. 
 
Informed Consent: 
Informed consent is a crucial part of this study. We will carefully explain the details of 
the research to each participant, ensuring they have a comprehensive understanding of what 
is involved. This includes information about the nature oftheir participation, possible risks, 
anticipated benefits, and their right to withdraw from the study. Additionally, as a token of 
appreciation for their valuablecontribution, participants will receive a small encouragement gift. 
Our aim is toprovide participants with all the information they need to make an informed 
decision about their involvement in the research. 
Study Duration: 
The expected length of the study is one year (15/12/2023 - 01/11/2024), whichincludes 
participant recruitment, intervention, follow-up, and data analysis. 
Study instruments : 
To ensure the validity and cultural appropriateness of the study instruments, we will review 
the available literature and consult with experts in the field to identify validated instruments that 
have been culturally adapted for use in Arabic and other commonly spoken languages in 
Qatar. If such instruments are available, we will incorporate them into our study. In the event 
that validated instruments are not readily available in the desired languages, we will try to 
undertake a careful process of cultural adaptation.This process will involve translation, 
back-translation, and cognitive interviewing to ensure that the instruments are linguistically 
and culturally appropriate for ourparticipants. 
 
Inclusion Criteria: 
Eligible participants for this study will be adult females aged 18 years and above, who 
have recently undergone episiotomy or cesarean section procedures. Specific inclusion criteria 
include: 
 
1. Adequate reading and writing literacy. 
2. Live term singleton pregnancy. 
3. Mediolateral episiotomy without tear. 
4. Absence 
of 
chronic 
systemic 
diseases 
that 
delay 
wound 
healing 
(e.g., 
coagulation disorders, diabetes, anemia (Hb) < 9 g/dl). 
5. No history of previous injury, surgery, or visible lesions in the perineum 
(e.g., genital warts, hemorrhoids). 

HMC RESEARCH 
PROTOCOL 
11 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
6. Does NOT have chorioamnionitis and/or postpartum endomyometritis 
7. No manual removal of placenta. 
8. No postpartum hemorrhage (PPH). 
9. Absence of perineal hematoma. 
10. Infant weight between 2500 and 4000 g. 
Exclusion Criteria: 
1. Use of other supplements or medications for wound healing during the study. 
2. Inability to apply the ointment correctly as per instruction. 
3. Sensitivity or allergy to the ointment or its components. 
4. Participants who have a history of adverse reactions to similar topical 
treatments. 
5. Participants who are unable to comply with study procedures and follow-up 
visits. 
Note : The assessment of participants use of other supplements or medications duringthe study 
will be conducted through a combination of self-reporting and verification during regular 
follow-up visits. Participants will be asked to disclose any additionalsupplements or medications 
they are using, and this information will be cross-checked with their medical records in Cerner. 
Additionally, healthcare providers will activelyinquire about any changes in medication or 
supplementation during follow-up visits. 
 
Data Collection: 
Data collection will involve objective measures and participant-reported outcomes. The 
assessment will include wound healing progress, scar appearance, pain levels, and patient 
satisfaction. These parameters will be assessed at predetermined intervals using standardized 
assessment tools and scoring systems. 
 
Sample Size Calculation: 
A sample size calculation has been performed to determine the required number of participants 
in each age and BMI stratum based on the expected effect size and statistical power. 
 
Study Location: 
This study will take place at Al-Wakra hospital. 
 
8. Study procedures 
We plan to start the study as soon as MRC approval is obtained, and MRC approval letter is 
issued. The expected length of the study is one year. 
Following MRC approval, we will start to stratify and recruit the patients based on inclusion 

HMC RESEARCH 
PROTOCOL 
12 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
and exclusion criterias . A research code (e.g. YK001) will be assign topatient to ensure 
privacy. A separate sheet will be kept with the PI including identifier date for each code). One 
of the investigators will then record the patients for inclusion. They will then be assigned the 
subject number code and the study variables will be recorded in a separate excel file under the 
patient’s subject code. 
• Study is expected to last 12 months (01/11/2023 -01/11/2024). 
 
Timeline: 
• Submission and approval of study (2 months) 
• Data collection, cleaning, and analysis (5 months) 
• result collation, 
interpretation, 
writing 
of 
manuscripts 
and 
dissemination 
(5 
months). 
 
 
Informed Consent 
Yes (attached) 
9. Risk 
All collected data will be coded so as to avoid any risk of confidentiality breach. 
Here are some potential anticipated risks to consider: 
 
• Allergic reactions: Some participants may experience allergic reactions to the topical 
treatments, HM Gel, or BS Ointment. Allergic reactions can range from mild skin irritation 
to more severe symptoms, such as rash, itching, or swelling. 
• Skin irritation: As with any topical treatment, there is a possibility of skin irritation at 
the application site. Participants may experience redness, itching, or discomfort around the 
wound area. 
• Delayed wound healing: There is a small possibility that the application of the treatments 
may interfere with the natural wound healing process, leading to delayed wound closure 
or complications in some participants. 
• Unsatisfactory scar appearance: Despite the use of the treatments, some participants 
may not achieve the desired cosmetic outcomes in scar appearance.This could potentially 
impact patient satisfaction with the treatment. 
• No treatment effect: It's possible that neither treatment (HM Gel or BS Ointment) 
may demonstrate a significant effect on wound healing or scar management, leading 
to no substantial improvement in the participants' conditions. 

HMC RESEARCH 
PROTOCOL 
13 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
• Infection: Although both treatments are topical and not invasive, there is still a small 
risk of infection at the wound site due to various factors, such as inadequate wound 
care or microbial contamination. 
Participants will be informed of these potential risks during the informed consent process, 
allowing them to make an informed decision about their participation in the research. 
 
Bio-Specimens & Sample Collection 
Not applicable 
Outcomes 
1- The primary outcome of this trial is to assess the effectiveness of Hydrophilic Methacrylate 
Gel (Hemagel) in promoting wound healing and reducing complications in patients 
undergoing episiotomy or cesarean section procedures. Specifically, we aim to compare the 
rate and quality of wound healing betweenthe group receiving Hemagel Ointment and 
the control group. 
 
2- The secondary outcome includes evaluating the impact of Hydrophilic Methacrylate Gel 
on pain management, scar appearance, and patient satisfaction. We will assess pain 
levels using standardized pain scales and compare the effectiveness of Hemagel Ointment 
in alleviating pain compared to the control group. Additionally, scar appearance will be 
evaluated using validatedassessment tools to determine if Hemagel Ointment leads to 
improved cosmetic outcomes. Patient satisfaction will be assessed through questionnaires 
to gaugethe subjective experience and level of satisfaction with the treatment. 
 
By achieving these objectives, this trial aims to provide evidence regarding the effectiveness 
of Hydrophilic Methacrylate Gel in promoting wound healing, managing pain, improving 
scar appearance, and enhancing patient satisfaction in the context of post-episiotomy and 
cesarean section scar. 
 
Data Collection & Confidentiality 
 
The patients name, medical record number and subject number will be recorded in a separate 
file. This file will be kept on a password locked computer at PIs office at pharmacy department 
of Al Wakra hospital. 
The assigned subject number will be used to record all the study variables. No physical copies 
will be used and data will not be shared outside HMC. 

HMC RESEARCH 
PROTOCOL 
14 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
The principal investigator will control access to this study’s data. 
Once patients are chosen, Cerner database will be reviewed for details pertinent to the study. 
The data will be collected as per the data collection sheet, which is attached for review. The 
PI is the one to collect the data in excel sheet and stored in a soft copy. 
Access for data collected will be under control of the principal investigator. 
Data will be collected de-identified, codes will be used to cover patient identifiers suchas 
Name, HC no., DOB. Any link between code and identifier will be deleted at the end 

HMC RESEARCH 
PROTOCOL 
15 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
of the data collection and anonymized data will be kept for at least 5 years after study completion. 
Following MRC approval, a research code (e.g. YK001) will be assign to patient to ensure privacy. 
A separate sheet will be kept with the PI including identifier date for each code). One of the 
investigators will then record the names and medical record numbers of the patients for 
inclusion. They will then be assigned the subject number code and the study variables will be 
recorded in a separate excel file under the patient’s subject code. 
The linking sheet to the subject’s identifier will be kept in a secure locked place in the 
PI office and will be destroyed after data collection and will not be shared outsideHMC. 
Data have to be stored for 5 years post study completion. 
Subject Withdrawal/ Withdrawal of Consent 
In this study, participants have the right to withdraw from the trial at any time without providing 
a reason. Withdrawal of consent will not affect their current or future medical care. Participants 
who decide to withdraw from the study will be informed that they are free to do so without 
any negative consequences. Their decision to withdraw will be respected, and their data collected 
up to the point of withdrawal will be retained and included in the analysis, unless they 
specifically request their data to be removed. 
To ensure proper handling of participant withdrawal, the study team will clearly communicate 
the withdrawal process during the informed consent process. Participants will be provided 
with contact information for the study coordinator or principal investigator, who will be 
available to answer any questions or concerns related to the study or the withdrawal process. 
 
If a participant decides to withdraw their consent, their study participation will be terminated 
immediately. Any unused investigational product (HM Gel or BS Ointment)will be collected, 
and no further assessments or interventions will be performed on the participant. 
The reasons for withdrawal, if provided voluntarily by the participant, will be recordedto inform 
the study team of potential issues and ensure continuous improvement of the research process. 
Participant confidentiality will be strictly maintained throughout the study and beyond. All 
data obtained from participants who withdraw their consent will be handled withthe utmost 
confidentiality and will not be disclosed in any study-related publications or presentations. 
It is important to emphasize that participant withdrawal is entirely voluntary, and participants 
will be assured that their decision will not impact their relationship with the 

HMC RESEARCH 
PROTOCOL 
16 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
healthcare providers or Al-Wakra hospital in any way. Their safety and well-being will remain 
a top priority throughout the study, regardless of their decision to continue or withdraw from the 
trial. 
 
10. Statistical Consideration and Data Analysis : 
 
Randomization and Allocation Concealment: 
We will be blinding the tube ointments to ensure impartiality in the assessment of efficacy between 
the two treatments. This adjustment will enable us to minimize potential biases and ensure the 
integrity of our results. 
The ointment tubes will be packaged in identical outer packaging, such as opaque boxes, to conceal 
any distinguishing features. 
This approach will ensure that the participants nor the assessors of wound know which ointment 
is being used. Blinding of data analysts will help ensure impartiality during the analysis process. 
 
Randomization: We will indeed use computer-generated random numbers or randomization 
software to ensure unbiased and unpredictable allocation. Instead of stratifying during 
randomization, we will collect comprehensive data on age group, BMI, and type of surgery. 
Subgroup analyses will be conducted during data analysis, allowing for a thorough examination 
of treatment effects within specific subgroups. 
 
Statistical Analysis Plan: 
The statistical analysis plan will be as follows: 
 
• Descriptive Statistics: 
Descriptive statistics will be used to summarize the demographic and baseline 
characteristics of the participants in both groups. Continuous variables, such as age 
and BMI, will be presented as means with standard deviations or medianswith interquartile 
ranges, depending on their distribution. Categorical variables,such as parity and type of 
surgery, will be summarized as frequencies and percentages. 
 
• Primary Outcome Analysis: 
The primary outcome of wound healing will be analyzed using appropriate statistical 
methods. As the wound healing outcome is likely to be a categorical variable (e.g., 
healed/not healed), we will employ the chi-square test or Fisher's exact test, depending on 
the expected cell  frequencies, to  compare  the proportions of healed wounds 

HMC RESEARCH 
PROTOCOL 
17 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
between the two treatment groups. 
• Secondary Outcome Analysis: 
For secondary outcomes, such as pain management, scar appearance, and patient 
satisfaction, we will use similar statistical methods. Pain management and patient 
satisfaction may be assessed using standardized pain scales and questionnaires, 
respectively. Depending on the distribution of the data, we will utilize t-tests or Mann- 
Whitney U tests to compare continuous variables and chi- square tests or Fisher's exact 
tests for categorical variables. 
 
• Intention-to-Treat (ITT) Analysis: 
The primary analysis will be conducted on an intention-to-treat (ITT) basis, including 
all randomized participants. This approach accounts for protocoldeviations and maintains 
the randomization balance between the groups. Participants will be analyzed according 
to their allocated treatment group, irrespective of protocol adherence or completion. 
 
• Subgroup Analyses: 
We will perform subgroup analyses to explore potential effect modifiers, such as age, BMI, 
or parity, on the treatment outcomes. Interaction tests or stratifiedanalyses may be 
employed to investigate the impact of these factors on theprimary and secondary outcomes. 
 
• Statistical Software: 
All statistical analyses will be performed using a reputable statistical software package, 
such as SPSS or R. These software tools are widely used for data analysis and will provide 
reliable results for this study. 
 
• Statistical Significance: 
Statistical significance will be defined as a p-value less than 0.05. Results with p-values 
less than this threshold will be considered statistically significant, indicating a significant 
difference between the treatment groups. 
 
• Who Will Perform the Analysis: 
The data analysis will be carried out by qualified statisticians Dr.Prem (HMC biostatician) 
with expertise in statistical methods. These individuals will be independent of the study's 
clinical team and will be blinded to the treatment allocation to ensure unbiased analysis. 

HMC RESEARCH 
PROTOCOL 
18 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
11. Adverse Event Reporting 
Monitoring and Reporting of Adverse Events: 
We will implement a systematic monitoring and reporting process to promptly identifyand assess 
adverse events throughout the study. The following steps will be followed: 
 
-Participant Education: Participants will be provided with clear instructions on how to recognize 
and report any potential adverse events they may experience during the study. They will be informed 
about the importance of timely reporting and the methods for contacting the study team. 
 
-Documentation: All adverse events reported by the participants or observed by the study 
personnel will be documented in detail. This documentation will include the natureof the event, 
date and time of occurrence, severity, duration, related symptoms, and any actions taken. 
 
-Classification and Severity Assessment: Adverse events will be classified and assessedfor 
severity according to predefined criteria. The severity levels may include mild, moderate, or severe, 
based on the impact on the participant's well-being and the need for medical intervention. 
 
-Causality Assessment: Adverse events will be evaluated for their potential relationshipto 
the investigational product (Hemagel Ointment) or other study procedures. Causality assessments 
will consider factors such as temporal association, known side effects of the product, and the 
presence of alternative explanations. 
 
-Reporting and Follow-up: Adverse events of moderate to severe intensity or those considered 
related to the investigational product will be promptly reported to the principal investigator 
and the relevant ethics committee or institutional review board (IRB). The reporting will include 
a comprehensive description of the event, its severity,the participant's characteristics, and any 
actions taken or planned. 
We will ensure that the reporting timelines align with the revised version of IRB SOP 09, available 
on the Abhath download center. Specifically, Serious Adverse Events (SAE) will be reported 
within 7 days, and any other unanticipated problems will be reported within 14 days. 
We are committed to ensuring the highest standards of participant safety and ethicalconduct 
throughout the study. 

HMC RESEARCH 
PROTOCOL 
19 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
- Follow-up and Documentation: Adverse events will be closely monitored and followedup until 
resolution or stabilization. The progress and outcomes of the adverse events, including any 
necessary medical interventions or treatments, will be documented in the participant's records. 
 
12. Ethical Consideration 
The study will only be conducted after review and approval from MRC. 
The study will be conducted in full conformance with principles of the “Declaration of Helsinki”, 
Good Clinical Practice (GCP) and within the laws and regulations of MoPHin Qatar.” 
13. Sponsor, Funding & Collaborator Information 
Not applicable 
14. Dissemination of Results and Publication policy 
Once the study is completed it will be sent for publication after review by the Medical Research 
center. We also plan to present the results of the study in various international conferences. 
 
References 
 
1. Cunningham, F. G., Leveno, K. J., Bloom, S. L., Spong, C. Y., Dashe, J. S., Hoffman, 
B. L., & Casey, B. M. (2018). Williams Obstetrics, Twenty-Fifth Edition. McGraw- 
Hill Education. 
 
2. Mustoe, T. A., Cooter, R. D., Gold, M. H., Hobbs, F. D., Ramelet, A. A., Shakespeare, 
P. G., & Ziegler, U. E. (2002). 
International clinical recommendations on 
scar 
management. Plastic and reconstructive surgery, 110(2), 560-571. 
 
3. Mustoe, T. A. (2008). Evolution of silicone therapy and mechanism of action in scar 
management. Aesthetic Plastic Surgery, 32(1), 82-92. 
 
4. Juckett, G., & Hartman-Adams, H. (2009). Management of keloids and hypertrophic 
scars. American Family Physician, 80(3), 253-260. 

HMC RESEARCH 
PROTOCOL 
20 
MRC-01-23-518 Validity: 06 12 2024 - 05 12 2025 E-stamped 04 Dec 2024 
 
 
5. Gold, M. H., Berman, B., Clementoni, M. T., Gauglitz, G. G., Nahai, F., Murcia, 
C., ... & Solish, N. (2014). Updated international clinical recommendations onscar 
management: part 2—algorithms for scar prevention and treatment. Dermatologic Surgery, 
40(8), 825-831. 
 
6. Sidgwick, G. P., McGeorge, D., & Bayat, A. (2015). A comprehensiveevidence-based 
review on the role of topicals and dressings in the managementof skin scarring. Archives 
of Dermatological Research, 307(6), 461-477. 
 
7. Winter, G. D. (1962). Formation of the scab and the rate of epithelization of superficial 
wounds in the skin of the young domestic pig. Nature, 193(4812), 293-294. 
 
8. Mustoe, T. A., Gurjala, A., The, M. H., Kirschner, R. E., Ragoowansi, R., Susarla, 
S., ... & Stotland, M. A. (2009). Dermal tissue regeneration by a small peptide occurring 
in high yield in Xenopus laevis. Journal of Plastic, Reconstructive & Aesthetic Surgery, 
62(12), 1746-1752. 
 
Appendices 
Data collection sheet Questionnere/Survey and Research consent form.