Episiotomy, Episiotomy Wound, Healing, Perineal Laceration, Perineal Pain, Perineal Trauma
Conditions
Keywords
boric acid, wet dressing, perineal trauma, episiotomy, lacerations, postpartum care, perineal pain, wound healing
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).
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).
Interventions
OTHER2% Boric Acid Wet Dressing
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
OTHER0.9% Normal Saline Wet Dressing
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.
BEHAVIORALRoutine Care Group
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.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perineal Wound Healing (REEDA Scale Score) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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" |
Countries
Turkey (Türkiye)
Outcome results
None listed