Optimizing Early Cesarean Scar Healing

NCT07547462 | Completed

• 1 other identifier: 01-23-518
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section Scar; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Scar Pigmentation Assessed by Vancouver Scar Scale (VSS)

  Day 5 postpartum and Day 12 postpartum

• Scar Height Assessed by Vancouver Scar Scale (VSS)

  Day 5 postpartum and Day 12 postpartum

• Patient-Reported Pain Assessed by Patient and Observer Scar Assessment Scale (POSAS)

  Day 5 postpartum and Day 12 postpartum

• Patient-Reported Itching Assessed by Patient and Observer Scar Assessment Scale (POSAS)

  Day 12 postpartum

• Patient Satisfaction (Patient-Reported Outcome)

  Day 12 postpartum

Study Arms (2)

Beta-Sitosterol Ointment

ACTIVE COMPARATOR

Topical beta-sitosterol ointment applied to cesarean section incision site during early postoperative period

Drug: Beta-Sitosterol Ointment

Hydrophilic Methacrylate Gel

EXPERIMENTAL

Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site during early postoperative period

Drug: Hydrophilic Methacrylate Gel

Interventions

Beta-Sitosterol Ointment DRUG

Topical ointment containing beta-sitosterol applied to cesarean section incision site

Beta-Sitosterol Ointment

Hydrophilic Methacrylate Gel DRUG

Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site

Hydrophilic Methacrylate Gel

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female (only)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Al Wakra Hospital

Doha, 3050, Qatar

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 23, 2026
• Study Start: December 15, 2023
• Primary Completion: October 8, 2024
• Study Completion: November 1, 2024
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)