Use of Lactic Acid Gel for Intravaginal Use, 7 Applicators x 5ml, Bayer to Reduce Post-episiotomy Discomfort

NCT06978049 | Completed DMC

• 2 other identifiers: BD300519907230/31.01.2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective controlled study evaluates the efficacy of topical lactic acid gel in enhancing episiotomy wound healing and improving postpartum sexual quality of life.

Conditions

Episiotomy; Wound Healing; Postpartum Period

Keywords

Episiotomy; Wound Healing; Postpartum

Outcome Measures

Primary Outcomes (1)

• Episiotomy Wound Healing Score at 40 Days Postpartum

  Evaluation of the quality of episiotomy wound healing, assessed through visual inspection and clinical scoring at 40 days postpartum. Higher scores reflect better wound healing. Healing assessment was performed by the clinical care team using a standardized evaluation system to ensure consistency across participants.

  40 days postpartum

Secondary Outcomes (1)

• Increase in Quality of Sexual Life

  40 days postpartum

Study Arms (2)

Canesbalance Group

EXPERIMENTAL

Participants in this group received topical lactic acid gel (a commercial product from BAYER, Bucharest, Romania) applied once daily directly to the episiotomy site. Treatment began on day 7 postpartum and continued for seven consecutive days.

Drug: Topical Lactic Acid Gel (BAYER)

No Intervention Group

NO INTERVENTION

Participants in this group received standard postpartum care without the addition of lactic acid gel or any other specific wound-healing treatments. Healing occurred spontaneously according to routine clinical practice.

Interventions

Topical Lactic Acid Gel (BAYER) DRUG

Lactic acid gel, applied topically once daily to the episiotomy site, starting on postpartum day 7 for a total of seven consecutive days. Commercial product: BAYER (Bucharest, Romania).

Canesbalance Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only postpartum women aged 18 to 40 years who have undergone spontaneous vaginal delivery with mediolateral episiotomy are eligible for inclusion in this study. Male participants are not eligible, as the study specifically investigates female perineal wound healing and postpartum sexual quality of life.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-40 years
• Spontaneous vaginal delivery with mediolateral episiotomy at 38-40 weeks gestation
• No pre-existing wound healing disorders or infections
• Provided informed consent

You may not qualify if:

• Known hypersensitivity to lactic acid products
• Third- or fourth-degree perineal tears
• Gestational diabetes or immunosuppressive conditions
• Use of additional wound care treatments

Sponsors & Collaborators

• Saint Andrew Hospital Constanta: lead
• Ovidius University of Constanta: collaborator

Study Sites (1)

Saint Andrew Hospital

Constanța, Constanța County, 900184, Romania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 18, 2025
• Study Start: January 31, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)