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Completed

NCT Number: NCT07748182

Effect of Boric Acid Wet Dressing on Postpartum Perineal Healing and Pain

Perineal trauma, including episiotomy and first- or second-degree perineal tears, is a common postpartum condition associated with pain and delayed wound healing after vaginal birth. This randomized controlled trial aims to evaluate the effects of boric acid wet dressing on postpartum perineal wound healing and pain compared with normal saline wet dressing and routine perineal care. Ninety-one women with perineal trauma are randomly assigned to one of three study groups. The primary outcome is perineal wound healing assessed using the REEDA Scale. Secondary outcomes include general and activity-related perineal pain assessed using the Visual Analog Scale (VAS).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bilimleri Üniversitesi Süleymaniye Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

About this study

Perineal trauma, occurring as episiotomy or lacerations during vaginal delivery, is a significant postpartum issue associated with pain and delayed recovery. Boric acid is a micronutrient with established antiseptic, antifungal, and antibacterial properties that supports tissue repair by modulating fibroblast activity and reducing oxidative stress. This study is designed as a three-arm randomized controlled trial to evaluate the clinical efficacy of topical boric acid wet dressings compared to normal saline and routine dry care.

All participants, regardless of their group, received standardized face-to-face education on perineal hygiene, covering topics such as hand hygiene, proper cleaning techniques, and signs of infection.

The boric acid group receives a 2% boric acid wet dressing applied to the perineal area for 15 minutes twice daily for seven consecutive days in addition to routine postpartum care. The normal saline group receives a 0.9% normal saline wet dressing using the same procedure and frequency in addition to routine postpartum care. The routine care group receives standard postpartum perineal care without additional wet dressing.

Outcome assessments are performed at baseline (approximately the second postpartum hour), at the twelfth postpartum hour, at hospital discharge, and between postpartum days 10 and 15.

The primary outcome measure is perineal wound healing evaluated using the REEDA Scale. Secondary outcome measures include general perineal pain and activity-related pain during sitting, walking, breastfeeding, urination, and defecation assessed using the Visual Analog Scale (VAS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women aged 18 years or older. Vaginal birth with episiotomy or first- or second-degree perineal tear. No signs or symptoms of vaginal infection. No pregnancy or postpartum complications requiring additional treatment. Able to communicate in Turkish. Willing to participate and provide written informed consent.

Exclusion criteria

Third- or fourth-degree obstetric perineal tears. No perineal trauma after vaginal birth. Presence of vaginal infection. Pregnancy or postpartum complications requiring medical treatment. Inability to communicate in Turkish. Withdrawal of consent during the study. Failure to complete follow-up assessments.

Treatment and study plan

2% Boric Acid Wet Dressing

Other

This intervention involves the topical application of a 2% boric acid solution to the perineal trauma site. The solution is applied using sterile gauze for 15 minutes, twice daily. The procedure was initiated by the researcher in the hospital during the first 24 hours postpartum and continued by the participant at home for two additional days following discharge

0.9% Normal Saline Wet Dressing

Other

This intervention serves as an active comparison and involves the topical application of 0.9% sodium chloride (normal saline) to the perineal trauma site. The application protocol is identical to the experimental group: 15 minutes, twice daily, using sterile gauze. The intervention started in the hospital and was maintained for two days post-discharge.

Routine Care Group

Behavioral

All participants in the study received standardized face-to-face education and an informative brochure regarding perineal care. The education covered hand hygiene, proper cleaning techniques (front-to-back), signs of infection, importance of keeping the area clean and dry, and nutritional advice to prevent constipation. This ensured that all groups had a baseline level of knowledge regarding self-care.

Primary outcomes

  1. Perineal Wound Healing (REEDA Scale Score)

    Time frame: From the 2nd hour postpartum (baseline) up to the follow-up visit (between postpartum days 10 and 15)

    Perineal wound healing was assessed using the REEDA Scale, which evaluates five parameters: Redness, Edema, Ecchymosis, Discharge, and Approximation. Each parameter is scored from 0 to 3, with a total score ranging from 0 to 15. Higher scores indicate greater tissue trauma and poorer wound healing

Secondary outcomes

  1. Perineal Pain Intensity (Visual Analog Scale - VAS)

    Time frame: From the initial postpartum assessment (baseline) up to the follow-up visit (between postpartum days 10 and 15)

    General and functional perineal pain levels (during activities such as sitting, walking, and breastfeeding) were measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "severe pain"

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

The Effect of Boric Acid Wet Dressing on Perineal Wound Healing and Pain Level in Postpartum Perineal Care

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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