Optimizing Early Cesarean Scar Healing

April 16, 2026 updated by: Dr. Yehia El Khawly, Hamad Medical Corporation

Optimizing Early Cesarean Scar Healing: A Randomized Controlled Trial of Hydrophilic Methacrylate Gel Versus Beta-Sitosterol Ointment

This randomized controlled trial compares hydrophilic methacrylate gel versus beta-sitosterol ointment for early cesarean section scar healing. Adult women who underwent cesarean delivery were randomly assigned to receive either hydrophilic methacrylate gel (n=58) or beta-sitosterol ointment (n=59). Scar outcomes were assessed by trained nurses blinded to treatment allocation and by patients at two time points approximately 12 days apart. The primary outcome was scar redness measured by the Vancouver Scar Scale. Secondary outcomes included pigmentation, pliability, scar height, and patient-reported measures including pain, itching, satisfaction, and treatment recommendation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Wound healing following cesarean delivery is a complex biological process influenced by mechanical stress, inflammatory response, tissue perfusion, and patient-related factors. This prospective randomized single-blinded controlled trial enrolled adult women who underwent elective or emergency cesarean section at a tertiary care maternity hospital in Qatar. Exclusion criteria included surgical site infection at baseline, dermatological conditions affecting wound healing, hypersensitivity to study products, systemic inflammatory disease, or inability to attend follow-up. Participants were randomly assigned to receive either hydrophilic methacrylate gel (n=58) or beta-sitosterol ointment (n=59) applied to the cesarean incision site starting in the early postoperative period. Outcome assessments were performed by trained nurses blinded to treatment allocation and by patients at two time points approximately 12 days apart. Nurse-assessed outcomes used the Vancouver Scar Scale (vascularity/redness, pigmentation, pliability, scar height). Patient-reported outcomes used the Patient and Observer Scar Assessment Scale (pain, itching, color, thickness, stiffness, irregularity, satisfaction, perceived effectiveness, ease of application, likelihood of recommending treatment).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar, 3050
        • Al Wakra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Underwent elective or emergency cesarean section
  • Uncomplicated postoperative course at enrollment ((no infection or major complications)

Exclusion Criteria:

  • Evidence of surgical site infection at baseline
  • Known dermatological conditions affecting wound healing
  • Hypersensitivity to study products
  • Systemic inflammatory disease
  • Inability to attend follow-up appointments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Beta-Sitosterol Ointment
Topical beta-sitosterol ointment applied to cesarean section incision site during early postoperative period
Drug: Beta-Sitosterol Ointment
Topical ointment containing beta-sitosterol applied to cesarean section incision site
Experimental: Hydrophilic Methacrylate Gel
Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site during early postoperative period
Drug: Hydrophilic Methacrylate Gel
Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Scar Redness (Vascularity) Assessed by Vancouver Scar Scale (VSS)
Time Frame: Assessed at two time points: Day 5 postpartum and Day 12 postpartum
Measured using the Vancouver Scar Scale (VSS) - Vascularity subscale (score range: 0-3, where higher scores indicate worse redness), assessed by trained nurses blinded to treatment allocation.
Assessed at two time points: Day 5 postpartum and Day 12 postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Scar Pigmentation Assessed by Vancouver Scar Scale (VSS)
Time Frame: Day 5 postpartum and Day 12 postpartum
Measured using the Vancouver Scar Scale (VSS) - Pigmentation subscale (score range: 0-3, where higher scores indicate worse pigmentation).
Day 5 postpartum and Day 12 postpartum
Scar Height Assessed by Vancouver Scar Scale (VSS)
Time Frame: Day 5 postpartum and Day 12 postpartum
Measured using the Vancouver Scar Scale (VSS) - Height subscale (score range: 0-3, where higher scores indicate greater scar thickness).
Day 5 postpartum and Day 12 postpartum
Patient-Reported Pain Assessed by Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: Day 5 postpartum and Day 12 postpartum
Measured using the Patient and Observer Scar Assessment Scale (POSAS) - Pain item (score range: 1-10, where higher scores indicate worse pain).
Day 5 postpartum and Day 12 postpartum
Patient-Reported Itching Assessed by Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: Day 12 postpartum
Measured using the Patient and Observer Scar Assessment Scale (POSAS) - Itching item (score range: 1-10, where higher scores indicate worse itching).
Day 12 postpartum
Patient Satisfaction (Patient-Reported Outcome)
Time Frame: Day 12 postpartum
Patient-reported overall satisfaction with treatment (categorized as satisfied/very satisfied vs not satisfied).
Day 12 postpartum
Treatment Effectiveness Perception (Patient-Reported Outcome)
Time Frame: Day 12 postpartum
Patient-reported perceived effectiveness of treatment (categorized as effective/very effective vs not effective).
Day 12 postpartum
Likelihood of Treatment Recommendation (Patient-Reported Outcome)
Time Frame: Day 12 postpartum
Patient-reported likelihood of recommending the treatment to others (ordinal scale; higher values indicate greater likelihood).
Day 12 postpartum
Ease of Application (Patient-Reported Outcome)
Time Frame: Day 12 postpartum
Patient-reported ease of applying the topical treatment (ordinal scale; higher values indicate easier application).
Day 12 postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamad Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01-23-518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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