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COMPLETED
NCT07814781
NA

Optimizing Early Episiotomy Wound Healing

Sponsor: Hamad Medical Corporation

View on ClinicalTrials.gov

Summary

This randomized controlled trial compares hydrophilic methacrylate gel versus beta-sitosterol ointment for early episiotomy wound healing. A total of 107 women who underwent mediolateral episiotomy during vaginal delivery were allocated to receive either hydrophilic methacrylate gel (n=53) or beta-sitosterol ointment (n=54). Wound outcomes were assessed by trained observers blinded to treatment allocation and by patients at two time points approximately 12 days apart. The primary outcome was the REEDA score (Redness, Edema, Ecchymosis, Discharge, Approximation). Secondary outcomes included patient-reported pain, cosmetic appearance, satisfaction, perceived treatment effectiveness, ease of application, and likelihood of recommending treatment.

Official title: Optimizing Early Episiotomy Wound Healing: A Randomized Controlled Trial of Hydrophilic Methacrylate Gel Versus Beta-Sitosterol Ointment

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

107

Start Date

2023-12-15

Completion Date

2024-11-01

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DRUG

Beta-Sitosterol Ointment

Topical ointment containing beta-sitosterol applied to the episiotomy/perineal wound site

DRUG

Hydrophilic Methacrylate Gel

Hydrophilic methacrylate-based hydrogel applied to the episiotomy/perineal wound site

Locations (1)

Al Wakra Hospital

Doha, Qatar