No Closure vs Interrupted vs Continuous Subcutaneous Closure: Operative Time and Wound Outcomes

March 4, 2026 updated by: Metin Ayğar, Yuzuncu Yil University

Comparison of No Subcutaneous Closure, Interrupted Closure, and Continuous Non-locking Closure at Elective Cesarean Delivery

The goal of this clinical trial is to research whether different methods of suturing during elective cesarean delivery affect surgery time and early wound healing. The study includes adults undergoing elective cesarean delivery with subcutaneous fat thickness of at least 2 centimetres.

The main questions it aims to answer are:

  • Does the closure method change how long the surgery takes?
  • Does the closure method change the chance of wound problems by day ten after surgery (such as fluid collection under the skin or wound infection)?

The investigators will compare three approaches-no subcutaneous suturing, three interrupted sutures, and one continuous non-locking suture-to research if one method improves wound outcomes without meaningfully increasing operative time.

Participants will:

Receive one of the three closure methods during their cesarean delivery Return around day ten after surgery for a standardised wound examination and an ultrasound evaluation of the incision area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative wound morbidity after cesarean delivery, while relatively infrequent, contributes to maternal discomfort, delayed recovery, and increased health care utilization. Subcutaneous tissue management at closure is a potentially modifiable surgical step, and both the decision to approximate the subcutaneous layer and the suturing technique may influence early wound outcomes as well as operative efficiency. However, consensus is lacking regarding the optimal approach.

This prospective comparative study evaluates three standardized subcutaneous tissue closure strategies among adults undergoing elective cesarean delivery via Pfannenstiel incision with a subcutaneous adipose tissue thickness of at least two centimeters: (one) no subcutaneous suturing, (two) closure with three interrupted sutures, and (three) closure with a continuous non-locking single-layer suture. Participants are assigned in equal numbers to each strategy using a predefined sequential allocation based on operative order. The surgical technique and follow-up assessments are conducted according to a predefined protocol, and participants are blinded to group assignment.

The study focuses on two clinically relevant domains: operative duration and short-term wound outcomes. Operative efficiency is assessed using total surgery duration. Wound outcomes are assessed around postoperative day ten using both standardized clinical incision assessment (including signs suggestive of infection such as erythema, warmth, discharge, dehiscence, or separation) and incision-site ultrasonography to identify subcutaneous fluid collection and other wound-related findings. By comparing these commonly used closure strategies under standardized conditions, the study aims to determine whether subcutaneous closure technique meaningfully affects operative time and early wound morbidity following elective cesarean delivery.

Study Type

Interventional

Enrollment (Actual)

300

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 (Türkiye)
    • Tuşba
      • Van, Tuşba, Turkey (Türkiye), 65090
        • Van Yüzüncü Yil University

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Scheduled for elective cesarean delivery via Pfannenstiel incision at the study site
  • Subcutaneous adipose tissue thickness 2 cm or greater (measured intraoperatively/at time of surgery per protocol)
  • Able and willing to provide written informed consent
  • Willing to return for postoperative day 10 follow-up assessment (clinical exam and incision-site ultrasonography)

Exclusion Criteria:

  • Any condition associated with impaired wound healing (e.g., diabetes mellitus, autoimmune disease)
  • Current systemic corticosteroid use
  • Suspected or confirmed infection at the time of delivery, including chorioamnionitis
  • Premature rupture of membranes
  • Refusal or inability to provide informed consent

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
No Intervention: Subcutaneous Closure (No Suturing)
Participants undergo elective cesarean delivery with no subcutaneous closure prior to skin closure.
Experimental: Interrupted Subcutaneous Closure (Three Interrupted Sutures)
Participants undergo elective cesarean delivery with subcutaneous suturing using three interrupted sutures before skin closure.
Other: Suture technique, Interrupted closure (3 sutures)

Interrupted closure (3 sutures):

Subcutaneous adipose tissue is sutured with three interrupted sutures placed along the incision before routine skin closure.
Experimental: Continuous Non-locking Subcutaneous Closure (Single-layer Continuous Suture)
Participants undergo elective cesarean delivery with single-layer subcutaneous tissue suturing using a continuous, non-locking suture technique prior to skin closure
Other: Suture technique, Continuous non-locking closure

Continuous non-locking closure:

Subcutaneous adipose tissue is approximated with a single-layer continuous, non-locking running suture along the incision before routine skin closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall wound complications by postoperative day 10
Time Frame: Postoperative day 10
Proportion of participants with any wound complication at day 10, defined as any abnormal incision-site ultrasonography finding (e.g., subcutaneous fluid collection/seroma, hematoma, abscess, cavity formation) and/or clinical wound infection findings on standardized exam (e.g., discharge, dehiscence, erythema, warmth). Outcome is recorded as present vs absent.
Postoperative day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative duration
Time Frame: Day of surgery (intraoperative)
Total surgery duration recorded in minutes (operative time).
Day of surgery (intraoperative)

Collaborators and Investigators

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

Sponsor

Yuzuncu Yil University

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 30, 2022

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

October 20, 2022

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YuzuncuYılUniversity_CS_Suture

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data will be shared with qualified researchers upon reasonable request after publication of the primary results, subject to approval by the study team and completion of a data use agreement, to protect participant confidentiality.

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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