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

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.

Study Overview

• Status: Recruiting
• Conditions: Episiotomy
• Intervention / Treatment: Device: stapler skin closure; Procedure: absorbable suture group

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aysegul Kanik, MSc; Phone Number: +905308285953; Email: ayseglkrt82@gmail.com

Study Locations

• Turkey (Türkiye)
  • İzmir
    • Izmir, İzmir, Turkey (Türkiye), 35000
      • Recruiting
      • Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi
      • Contact: Aysegul Kanik, MSc; Phone Number: 05308285953; Email: ayseglkrt82@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stapler skin closure group; Episiotomy repair is performed using surgical staplers for skin closure in primiparous women.	Device: stapler skin closure; skin closure of episiotomy is performed using a surgical stapler.
Experimental: Absorbable suture group; Skin closure of episiotomy is performed using absorbable sutures.	Procedure: absorbable suture group; skin closure of episiotomy is performed using absorbable sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 6 hours, 24 hours and 7 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	10 days postpartum

Collaborators and Investigators

• Sponsor: Ayşegül Kanık

Publications and helpful links

General 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, C. W., Low, L. K., Kowalk, K. M., & Fenner, D. E. (2019). Randomized Trial Of 3 Techniques Of Perineal Skin Closure During Second-Degree Perineal Laceration Repair. Journal Of Midwifery & Women's Health, 64(5), 567-577.
• Woldegeorgis, B. Z., Obsa, M. S., Tolu, L. B., Bogino, E. A., Boda, T. I., & Alemu, H. B. (2022). Episiotomy Practice and Its Associated Factors in Africa: A Systematic Review and Meta-Analysis. Frontiers in Medicine, 1714.
• 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., ... & Mardani, G. (2018). The Effect Of Green Tea Ointment On Episiotomy Pain And Wound Healing in Primiparous Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Phytotherapy Research, 32(3), 522-530.
• JahaniShoorab, N., Zagami, S. E., Nahvi, A., Mazluom, S. R., Golmakani, N., Talebi, M., & Pabarja, F. (2015). The effect of virtual reality on pain in primiparity women during episiotomy repair: a randomize clinical trial. Iranian journal of medical sciences, 40(3), 219.
• Mastud, K., Lamture, Y., Nagtode, T., & Rewale, V. (2022). A Comparative Study Between Conventional Sutures, Staples, And Adhesive Glue For Clean Elective Surgical Skin Closure. Cureus, 14(11).
• Figueroa, D., Jauk, V. C., Szychowski, J. M., Garner, R., Biggio, J. R., Andrews, W. W., ... & Tita, A. T. (2013). Surgical Staples Compared With Subcuticular Suture For Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstetrics And Gynecology, 121(1).
• Feigenberg, T., Maor-Sagie, E., Zivi, E., Abu-Dia, M., Ben-Meir, A., Sela, H. Y., & Ezra, Y. (2014). Using Adhesive Glue To Repair First Degree Perineal Tears: A Prospective Randomized Controlled Trial. Biomed Research International, 2014.
• Corrêa, M. D., & Passini, R. (2016). Selective episiotomy: indications, techinique, and association with severe perineal lacerations. Revista Brasileira de Ginecologia e Obstetrícia, 38(06), 301-307.
• Deyaso, Z. F., Chekole, T. T., Bedada, R. G., Molla, W., Uddo, E. B., & Mamo, T. T. (2022). Prevalence of Episiotomy Practice and Factors Associated with it in Ethiopia, Systematic Review and Meta-analysis. Women's Health, 18, 17455057221091659.
• Chang, S. R., Chen, K. H., Lin, H. H., Chao, Y. M. Y., & Lai, Y. H. (2011). Comparison Of The Effects Of Episiotomy And No Episiotomy On Pain, Urinary İncontinence, And Sexual Function 3 Months Postpartum: A Prospective Follow-Up Study. International Journal Of Nursing Studies, 48(4), 409-418.
• Chamariya, S., Prasad, M., & Chauhan, A. (2016). Comparison Of Dermabond Adhesive Glue With Skin Suture For Repair Of Episiotomy. International Journal Of Reproduction, Contraception, Obstetrics And Gynecology, 5(10), 3461-3466.
• Akopov, A., Artioukh, D. Y., & Molnar, T. F. (2021). Surgical Staplers: The History Of Conception And Adoption. The Annals Of Thoracic Surgery, 112(5), 1716-1721.
• Beşen, M. A., & Rathfısch, G. (2019). Doğumda Perineal Travma ve Onarımı: Kanıt Temelli Yaklaşımlar. Gazi Sağlık Bilimleri Dergisi, 4(3), 1-11.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: episiotomy; stapler; primiparous women
• Other Study ID Numbers: THESIS-EPIS-PAIN-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to patient confidentiality and ethical considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No