The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain

June 10, 2025 updated by: Emre Kar, Başakşehir Çam & Sakura City Hospital

The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain: A Randomized Clinical Trial

Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Basaksehir
      • Istanbul, Basaksehir, Turkey, 34494
        • Çam and Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primiparous
  • Age between 18 to 45
  • Given birth in our labor ward

Exclusion Criteria:

  • Multiparous
  • having deep vaginal lacerations
  • having abnormalities in fetus
  • Rheumatologic diseases
  • Postpartum bleeding
  • Shoulder Dystocia
  • Operative Delivery
  • Using antithrombotic or anticoagulant medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I-Suture
Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm.
Procedure: Primary Suturing
Horizontal primary suture in interrupted fashion
Active Comparator: M-Suture
Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm.
Procedure: Mattress Suturing
Horizontal mattress suture in interrupted fashion
Active Comparator: SC-Suture
Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm.
Procedure: Continuous Subcutaneous Suturing
Subcutaneous suture in continuous fashion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain by Visual Analog Scale (VAS)
Time Frame: in postpartum day 15
Pain is assessed from 0 (none) to 10 (extreme) by Visual Analog Scale (VAS)
in postpartum day 15
Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score
Time Frame: in postpartum day 15

Healing is assessed by Redness, Edema, Ecchymosis and Discharge (REEDA) Score

REEDA Scale:

Healed: 0; moderately healed: 1 to 5; mildly healed: 6 to 10; and not healed: 11 to 15
in postpartum day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

September 20, 2022

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021.12.282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available upon request for at least 2 years after publication.

IPD Sharing Time Frame

IPD will be available upon request for at least 2 years after publication.

IPD Sharing Access Criteria

Contact with Corresponding Author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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