Optimizing Early Episiotomy Wound Healing

NCT07814781 | Completed

• 2 other identifiers: 01-23-518-EPISMRC-01-23-518
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Episiotomy; Perineal Wound Healing

Keywords

Episiotomy; Wound Healing; Hydrophilic Methacrylate Gel; Beta-Sitosterol Ointment; REEDA Scale; Postpartum

Outcome Measures

Primary Outcomes (1)

• Perineal Wound Healing Assessed by REEDA Scale

  Measured using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation) total score, where higher scores indicate worse wound healing, assessed by trained observers blinded to treatment allocation.

  Assessed at two time points: Day 5 postpartum and Day 12 postpartum

Secondary Outcomes (7)

• Complete Wound Healing (REEDA = 0) Assessed at Day 12

  Day 12 postpartum

• Patient-Reported Pain

  Day 12 postpartum

• Patient Satisfaction (Patient-Reported Outcome)

  Day 12 postpartum

• Treatment Effectiveness Perception (Patient-Reported Outcome)

  Day 12 postpartum

• Perineal Cosmetic Appearance (Patient-Reported Outcome)

  Day 12 postpartum

Study Arms (2)

Beta-Sitosterol Ointment

ACTIVE COMPARATOR

Participants applied Beta-Sitosterol ointment to the episiotomy/perineal wound site twice daily (morning and evening) for 2 weeks.

Drug: Beta-Sitosterol Ointment

Hydrophilic Methacrylate Gel

EXPERIMENTAL

Participants applied Hydrophilic methacrylate gel to the episiotomy/perineal wound site twice daily (morning and evening) for 2 weeks.

Drug: Hydrophilic Methacrylate Gel

Interventions

Beta-Sitosterol Ointment DRUG

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

Beta-Sitosterol Ointment

Hydrophilic Methacrylate Gel DRUG

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

Hydrophilic Methacrylate Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Primigravida (first pregnancy)
• Live term singleton pregnancy
• Underwent mediolateral episiotomy without tear during vaginal delivery
• Adequate reading and writing literacy

You may not qualify if:

• Known dermatological conditions affecting wound healing
• Hypersensitivity to study products
• Systemic inflammatory disease
• Chronic systemic disease that delays wound healing (e.g., coagulation disorders, diabetes, anemia with Hb \<9 g/dl)
• Prior perineal injury, surgery, or visible lesions (e.g., genital warts, hemorrhoids)
• 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: September 6, 2026
• First Posted: September 11, 2026
• Study Start: December 15, 2023
• Primary Completion: October 8, 2024
• Study Completion: November 1, 2024
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)