Ireland
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Recruiting Not applicable

THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN

NCT07383623 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ayşegül Kanık
Phase
Not applicable
Started
2025-10-01
Last updated
2026-02-10

Condition(s) studied

Episiotomy

Investigational drug(s) / intervention(s)

stapler skin closureabsorbable suture group

stapler skin closure: skin closure of episiotomy is performed using a surgical stapler.

absorbable suture group: skin closure of episiotomy is performed using absorbable sutures.

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
49 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age ≥ 18 years * Term pregnancy (≥ 37 weeks) * Low-risk pregnancy (no obstetric risk factors) * Not receiving oxytocin induction during latent or active labor * Singleton pregnancy with a live fetus * No psychiatric disorder * No substance abuse * Primiparous women (first vaginal birth) * Presence of 1st or 2nd degree perineal tear * Able to read, understand, and voluntarily provide written and verbal informed consent. Exclusion Criteria: * Apgar score \< 7 at 1 minute and/or 5 minutes * Neonatal anomaly * Use of \>10 mL analgesic during episiotomy repair beyond routine practice * Obesity * Vaginal infection or vaginal lesion * Maternal conditions impairing wound healing (e.g., diabetes mellitus, immunosuppression, coagulation disorders) * 3rd or 4th degree perineal tear * Shoulder dystocia / difficult delivery

Primary outcome measure(s)

  • postpartum perineal pain — At 6 hours, 24 hours and 7 days postpartum
    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.

Trial sites (1)

FacilityCityRegionStatus
Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi Izmir İzmir Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07383623 on ClinicalTrials.gov ↗ ← All trials in Turkey