Use of Lactic Acid Gel for Intravaginal Use, 7 Applicators x 5ml, Bayer to Reduce Post-episiotomy Discomfort (LA30051990)

Saint Andrew Hospital Constanta

Status: Completed

Conditions: Wound Healing; Episiotomy; Postpartum Period

Treatments: Drug: Topical Lactic Acid Gel (BAYER)

Study type: Interventional

Funder types: Other

Identifiers

NCT06978049

7230/31.01.2023 (Registry Identifier)

BD30051990

Details and patient eligibility

About

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

Full description

This prospective controlled clinical study aims to evaluate the efficacy of topical lactic acid gel in promoting the healing of episiotomy wounds and improving postpartum sexual quality of life.

The study was conducted at the County Clinical Emergency Hospital "Sf. Ap. Andrei" in Constanța, Romania, between February 1, 2023, and December 31, 2024, with ethical approvals obtained from both the Ethics Committee of Ovidius University of Constanța (No. 01/20.01.2023) and the Saint Andrew Hospital Ethics Committee (No. 7230/31.01.2023).

A total of 100 postpartum women aged 18 to 40 years, who underwent spontaneous vaginal delivery with mediolateral episiotomy at a gestational age of 38-40 weeks, were enrolled in the study after providing informed consent. Participants were sequentially assigned into two parallel groups:

Experimental Group (n = 50): Received topical lactic acid gel (commercially available formulation from BAYER, Bucharest, Romania) applied once daily directly to the episiotomy site, starting seven days postpartum, for a total duration of seven consecutive days.

Control Group (n = 50): Received standard postpartum care without additional topical treatments, allowing for spontaneous healing of the episiotomy wound.

The primary endpoint was the assessment of episiotomy wound healing quality at 40 days postpartum, determined via visual inspection and healing scoring. The secondary endpoint was the evaluation of postpartum sexual function, assessed using a validated 12-item sexual quality of life questionnaire specifically designed for postpartum women. The questionnaire addressed domains including sexual desire, orgasm frequency, sexual satisfaction, pain during intercourse (dyspareunia), vaginal dryness, emotional well-being during intercourse, and partner-related factors. Higher total scores reflected better sexual health and satisfaction.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Canesbalance Group

Experimental group

Description:

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.

Treatment:

Drug: Topical Lactic Acid Gel (BAYER)

No Intervention Group

No Intervention group

Description:

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.