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

NCT07748182 | Completed

• 1 other identifier: 2023/285
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healing; Perineal Trauma; Episiotomy Wound; Perineal Pain; Perineal Laceration; Episiotomy

Keywords

boric acid; wet dressing; perineal trauma; episiotomy; lacerations; postpartum care; perineal pain; wound healing

Outcome Measures

Primary Outcomes (1)

• Perineal Wound Healing (REEDA Scale Score)

  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

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

Secondary Outcomes (1)

• Perineal Pain Intensity (Visual Analog Scale - VAS)

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

Study Arms (3)

Boric Acid Group

EXPERIMENTAL

Participants in this group received a 2% boric acid wet dressing applied to the perineal trauma area for 15 minutes, twice daily. The application was initiated in the hospital and continued for two days following discharge

Other: 2% Boric Acid Wet Dressing; Behavioral: Routine Care Group

Normal Saline Group

ACTIVE COMPARATOR

Participants in this group received a 0.9% sodium chloride (normal saline) wet dressing applied to the perineal trauma area for 15 minutes, twice daily. The application protocol was identical to the boric acid group

Other: 0.9% Normal Saline Wet Dressing; Behavioral: Routine Care Group

Routine Care Group

OTHER

Participants in this group followed the standard clinical routine of the facility, which consists of keeping the perineal area clean and dry. They received only perineal hygiene education without any wet dressing application

Behavioral: Routine Care Group

Interventions

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

Boric Acid Group

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.

Normal Saline Group

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.

Boric Acid Group; Normal Saline Group; Routine Care Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi Süleymaniye Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (8)

• Bakır, S., Gök, E., Gün, S., Kavlak, O. (2024). Vajinal doğum yapan kadınların epizyotomi ile ilgili görüşleri ve doğum memnuniyeti. TOGÜ Sağlık Bilimleri Dergisi, 4 (1), 50-65.

  BACKGROUND

• Alvarenga MB, Francisco AA, de Oliveira SM, da Silva FM, Shimoda GT, Damiani LP. Episiotomy healing assessment: Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale reliability. Rev Lat Am Enfermagem. 2015 Jan-Feb;23(1):162-8. doi: 10.1590/0104-1169.3633.2538.

  PMID: 25806645 BACKGROUND

• WHO recommendations on maternal and newborn care for a positive postnatal experience [Internet]. Geneva: World Health Organization; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK579657/

  PMID: 35467813 BACKGROUND

• Roma NZH, Essa RM, Rashwan ZI, Ahmed AH. Effect of Dry Heat Application on Perineal Pain and Episiotomy Wound Healing among Primipara Women. Obstet Gynecol Int. 2023 Jan 4;2023:9572354. doi: 10.1155/2023/9572354. eCollection 2023.

  PMID: 36643188 BACKGROUND

• Cobanoglu A, Sendir M. [Evidence-Based Practices in Episiotomy Care]. Florence Nightingale Hemsire Derg. 2019 Feb 1;27(1):48-62. doi: 10.26650/FNJN345977. eCollection 2019 Feb. Turkish.

  PMID: 34267962 BACKGROUND

• Andrews V, Thakar R, Sultan AH, Jones PW. Evaluation of postpartum perineal pain and dyspareunia--a prospective study. Eur J Obstet Gynecol Reprod Biol. 2008 Apr;137(2):152-6. doi: 10.1016/j.ejogrb.2007.06.005. Epub 2007 Aug 2.

  PMID: 17681663 BACKGROUND

• ACOG Committee Opinion No. 742: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):e35-e43. doi: 10.1097/AOG.0000000000002683.

  PMID: 29781876 BACKGROUND

• Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.

  PMID: 28608597 BACKGROUND

Related Links

• ACOG recommendations for postpartum pain management, supporting the study's outcome measures.
• World Health Organization (WHO) Postnatal Care Guidelines, which provide the framework for the study's routine care.

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

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

Model Details: This study is a three-arm randomized controlled trial with a parallel assignment design. Participants who experienced first or second-degree perineal trauma during vaginal delivery were randomly assigned to one of three parallel groups: a boric acid wet dressing group, a normal saline wet dressing group, or a routine dry care (control) group. The interventions were initiated in the hospital and continued for the first two days following discharge. All participants were followed simultaneously according to the same clinical observation protocol

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 5, 2026
• Study Start: January 10, 2025
• Primary Completion: June 26, 2026
• Study Completion: June 26, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)