An interventional study of 2% Boric Acid Wet Dressing and 0.9% Normal Saline Wet Dressing in Perineal Trauma, Episiotomy and Episiotomy Wound, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care
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).
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).
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's enrollment of 91 is above the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
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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 .
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
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.
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
Time frame: From the 2nd hour postpartum (baseline) up to the follow-up visit (between postpartum days 10 and 15)
Perineal Pain Intensity (Visual Analog Scale - VAS)
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"
Time frame: From the initial postpartum assessment (baseline) up to the follow-up visit (between postpartum days 10 and 15)
Plan to share: No — Individual participant data will not be shared to ensure the strict confidentiality and privacy of the participants, as stated in the informed consent forms. Study results will be shared through the final thesis and future academic publications
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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