About this trial
This randomized controlled study aims to evaluate the effects of skin closure using surgical staplers compared with conventional skin sutures on postoperative pain and wound healing in primiparous women undergoing episiotomy repair after vaginal delivery.
Primiparous women who require episiotomy during vaginal birth will be randomly assigned to one of two groups: skin closure with staples or skin closure with sutures. Postpartum pain levels and wound healing outcomes will be assessed and compared between the two groups.
The results of this study are expected to contribute to evidence-based decisions regarding optimal skin closure techniques in episiotomy repair.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Term pregnancy (≥ 37 weeks)
Low-risk pregnancy (no obstetric risk factors)
Not receiving oxytocin induction during latent or active labor
Disqualifiers
Apgar score < 7 at 1 minute and/or 5 minutes
Neonatal anomaly
Use of >10 mL analgesic during episiotomy repair beyond routine practice
Obesity
Trial design
Parallel
Treatments tested in this trial
stapler skin closure
Deviceskin closure of episiotomy is performed using a surgical stapler.
absorbable suture group
Procedure/Surgeryskin closure of episiotomy is performed using absorbable sutures.
Treatment groups
Trial outcomes
Primary outcomes
postpartum perineal pain
Perineal pain severity will be assessed using the Visual Analog Scale (VAS) following episiotomy repair. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain severity.
Secondary outcomes
Episiotomy wound healing
Wound healing will be assessed using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation). The total REEDA score ranges from 0 to 15, with lower scores indicating better wound healing and higher scores indicating worse wound healing.Wound healing assessed using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation)
Sponsors and contacts
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Ayşegül Kanık
Lead sponsor
Ege University
Sponsor institution