NCT07383623

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

THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN: A RANDOMIZED CONTROLLED TRIAL

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ayşegül Kanık · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

Episiotomy is one of the most commonly performed obstetric interventions during childbirth. Although it shares similar characteristics with spontaneous second-degree perineal tears, episiotomy was routinely performed for many years. However, routine episiotomy practices began to be questioned in the late 1970s and 1980s, and its use declined during the 1990s. Factors contributing to this change include increased health awareness among women, the natural childbirth movement, professional competition, and the widespread adoption of evidence-based practices. Pain associated with episiotomy is a significant issue that negatively affects women's quality of life in the postpartum period. A woman's request for analgesia is considered a medical indication for pain management. Inadequate pain control reduces the effectiveness of therapeutic interventions. Episiotomy-related pain decreases maternal comfort, negatively affects mother-infant bonding, reduces breastfeeding success, and may even influence women's childbirth preferences due to fear of labor and episiotomy pain. The ideal method for episiotomy repair should be fast, easy to perform, cause minimal tissue trauma, and result in minimal postpartum pain and dyspareunia. Closure techniques that minimize skin trauma reduce inflammation and scarring by limiting the introduction of foreign materials. Various techniques have been proposed for postpartum episiotomy repair, including non-suturing of the incision, continuous locking sutures, and interrupted non-locking sutures. Regardless of the technique used, successful tissue approximation is associated with less pain and wound infection, better cosmetic outcomes, and shorter hospital stays. In recent years, traditional repair methods have increasingly been replaced by modern techniques such as skin staples, tissue adhesives, and adhesive strips. Skin staples, one of these modern methods, are described as a faster and more reliable repair technique. Due to their fixed depth and uniform structure, staples provide equal wound tension, which is thought to reduce pain and promote wound healing in episiotomy skin repair. The aim of this study is to determine the effects of using staples versus surgical sutures in episiotomy skin repair on postpartum localized pain and wound healing.

Conditions

• Episiotomy

Interventions

Type	Name	Description
DEVICE	stapler skin closure	skin closure of episiotomy is performed using a surgical stapler.
PROCEDURE	absorbable suture group	skin closure of episiotomy is performed using absorbable sutures.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-05-01
• Completion: 2026-06-30
• First posted: 2026-02-03
• Last updated: 2026-02-10

Locations

1 site across 1 country: Turkey (Türkiye)