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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• postpartum perineal pain [Time frame: At 6 hours, 24 hours and 7 days postpartum]

Secondary outcome measures (1)

• Episiotomy wound healing [Time frame: 10 days postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi — Izmir

Publications

• Teixeira, T. T., Caroci-Becker, A., Brunelli, W. S., & Riesco, M. L. G. (2020). Tissue Adhesive To Repair First-Degree Perineal Tear: A Pilot Randomized Controlled Trial. Clinical And Experimental Obstetrics And Gynecology, 47(2), 228-233.
• Swenson CW, Low LK, Kowalk KM, Fenner DE. Randomized Trial of 3 Techniques of Perineal Skin Closure During Second-Degree Perineal Laceration Repair. J Midwifery Womens Health. 2019 Sep;64(5):567-577. doi: 10.1111/jmwh.13020. Epub 2019 Aug 21. PMID 31433108
• Woldegeorgis BZ, Obsa MS, Tolu LB, Bogino EA, Boda TI, Alemu HB. Episiotomy Practice and Its Associated Factors in Africa: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2022 Jun 24;9:905174. doi: 10.3389/fmed.2022.905174. eCollection 2022. PMID 35865171
• Sherif, A., & El-Shourbagy, M. (2020). Skin-Adhesive Tape Versus Interrupted Suture İn Episiotomy Skin Repair: Randomized Control Trial. Open Journal Of Obstetrics And Gynecology, 10(02), 254.
• Shahrahmani H, Kariman N, Jannesari S, Rafieian-Kopaei M, Mirzaei M, Ghalandari S, Shahrahmani N, Mardani G. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2018 Mar;32(3):522-530. doi: 10.1002/ptr.5999. Epub 2017 Dec 13. PMID 29235159
• JahaniShoorab N, Ebrahimzadeh Zagami S, Nahvi A, Mazluom SR, Golmakani N, Talebi M, Pabarja F. The Effect of Virtual Reality on Pain in Primiparity Women during Episiotomy Repair: A Randomize Clinical Trial. Iran J Med Sci. 2015 May;40(3):219-24. PMID 25999621
• Mastud K, Lamture Y, Nagtode T, Rewale V. A Comparative Study Between Conventional Sutures, Staples, and Adhesive Glue for Clean Elective Surgical Skin Closure. Cureus. 2022 Nov 7;14(11):e31196. doi: 10.7759/cureus.31196. eCollection 2022 Nov. PMID 36505125
• Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c. PMID 23262925

Identifiers

NCT: NCT07383623 · THESIS-EPIS-PAIN-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗