Optimizing Early Cesarean Scar Healing

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: Completed
• Conditions: Wound Healing; Cesarean Section Scar
• Intervention / Treatment: Drug: Beta-Sitosterol Ointment; Drug: Hydrophilic Methacrylate Gel

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: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Scar Redness (Vascularity) Assessed by Vancouver Scar Scale (VSS)	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

Outcome Measure	Measure Description	Time Frame
Scar Pigmentation Assessed by Vancouver Scar Scale (VSS)	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)	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)	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)	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)	Patient-reported overall satisfaction with treatment (categorized as satisfied/very satisfied vs not satisfied).	Day 12 postpartum
Treatment Effectiveness Perception (Patient-Reported Outcome)	Patient-reported perceived effectiveness of treatment (categorized as effective/very effective vs not effective).	Day 12 postpartum
Likelihood of Treatment Recommendation (Patient-Reported Outcome)	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)	Patient-reported ease of applying the topical treatment (ordinal scale; higher values indicate easier application).	Day 12 postpartum

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID 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