Perineal TraumaNCT07748182
Effect of Boric Acid Wet Dressing on Postpartum Perineal Healing and Pain
A study testing 2% Boric Acid Wet Dressing, 0.9% Normal Saline Wet Dressing and Routine Care Group in people with Perineal Trauma and Episiotomy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Trauma, Episiotomy, Episiotomy Wound
- What is being tested?
- 2% Boric Acid Wet Dressing, 0.9% Normal Saline Wet Dressing and Routine Care Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Süleymaniye Eğitim ve Araştırma Hastanesi
Istanbul
About this study
Official title: The Effect of Boric Acid Wet Dressing on Perineal Wound Healing and Pain Level in Postpartum Perineal 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).
Read the detailed description
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).
- Conditions
- Perineal Trauma, Episiotomy, Episiotomy Wound, Perineal Pain, Perineal Laceration, Healing
- Being tested
- 2% Boric Acid Wet Dressing, 0.9% Normal Saline Wet Dressing, Routine Care Group
- Keywords
- boric acid, wet dressing, perineal trauma, episiotomy, lacerations, postpartum care, perineal pain, wound healing
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Boric Acid Wet DressingOther
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 DressingOther
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Behavioral: Routine Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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"
Measured: From the initial postpartum assessment (baseline) up to the follow-up visit (between postpartum days 10 and 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start10 Jan 2025
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Perineal TraumaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Çalışkan, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748182
- Sponsor's protocol ID
- 2023/285
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
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.
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.
PubMed 25806645WHO 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/
PubMed 35467813Roma 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.
PubMed 36643188Cobanoglu 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.
PubMed 34267962Andrews 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.
PubMed 17681663ACOG Committee Opinion No. 742: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):e35-e43. doi: 10.1097/AOG.0000000000002683.
PubMed 29781876Aasheim 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.
PubMed 28608597
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Boric Acid Wet Dressing on Perineal Wound Healing and Pain Level in Postpartum Perineal Care
- ClinicalTrials.gov ID
- NCT07748182
- Acronym / sponsor ID
- 2023/285
- Conditions
- Perineal Trauma, Episiotomy, Episiotomy Wound, Perineal Pain, Perineal Laceration, Healing
- Keywords
- boric acid, wet dressing, perineal trauma, episiotomy, lacerations, postpartum care, perineal pain, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Boric Acid Group | Experimental | Other: 2% Boric Acid Wet Dressing, Behavioral: Routine Care GroupParticipants 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 |
| Normal Saline Group | Active comparator | Other: 0.9% Normal Saline Wet Dressing, Behavioral: Routine Care GroupParticipants 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 |
| Routine Care Group | Other | Behavioral: Routine Care GroupParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Boric Acid Wet DressingThis 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 | Other | Boric Acid Group |
| 0.9% Normal Saline Wet DressingThis 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. | Other | Normal Saline Group |
| Routine Care GroupAll 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. | Behavioural | Boric Acid Group, Normal Saline Group, Routine Care Group |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- BackgroundBakır, 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: PubMed 25806645Alvarenga 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.
- Background: PubMed 35467813WHO 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/
- Background: PubMed 36643188Roma 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.
- Background: PubMed 34267962Cobanoglu 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.
- Background: PubMed 17681663Andrews 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.
- Background: PubMed 29781876ACOG Committee Opinion No. 742: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):e35-e43. doi: 10.1097/AOG.0000000000002683.
- Background: PubMed 28608597Aasheim 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.
- ACOG recommendations for postpartum pain management, supporting the study's outcome measures.Link provided by the sponsor.
- World Health Organization (WHO) Postnatal Care Guidelines, which provide the framework for the study's routine care.Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Boric Acid Wet Dressing, 0.9% Normal Saline Wet Dressing and Routine Care Group in people with Perineal Trauma and Episiotomy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07748182, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.