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

NCT07451275 | Completed

• 1 other identifier: YuzuncuYılUniversity_CS_Suture
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Wound Infection; Suture; Suture Techniques; Ceserean Section

Keywords

Cesarean Delivery; Subcutaneous Tissue Closure; Subcutaneous Suturing; Interrupted Suture; Continuous Non-locking Suture; Surgical Site Infection; Subcutaneous Fluid Collection

Outcome Measures

Primary Outcomes (1)

• Overall wound complications by 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 Outcomes (1)

• Operative duration

  Day of surgery (intraoperative)

Study Arms (3)

Subcutaneous Closure (No Suturing)

NO INTERVENTION

Participants undergo elective cesarean delivery with no subcutaneous closure prior to skin closure.

Interrupted Subcutaneous Closure (Three Interrupted Sutures)

EXPERIMENTAL

Participants undergo elective cesarean delivery with subcutaneous suturing using three interrupted sutures before skin closure.

Other: Suture technique, Interrupted closure (3 sutures)

Continuous Non-locking Subcutaneous Closure (Single-layer Continuous Suture)

EXPERIMENTAL

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

Interventions

Suture technique, Interrupted closure (3 sutures) OTHER

Interrupted closure (3 sutures): Subcutaneous adipose tissue is sutured with three interrupted sutures placed along the incision before routine skin closure.

Interrupted Subcutaneous Closure (Three Interrupted Sutures)

Suture technique, Continuous non-locking closure OTHER

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.

Continuous Non-locking Subcutaneous Closure (Single-layer Continuous Suture)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, Tuşba, 65090, Turkey (Türkiye)

Location

Related Publications (2)

• Carbonnel M, Brot D, Benedetti C, Kennel T, Murtada R, Revaux A, Ayoubi JM. Risks factors FOR wound complications after cesarean section. J Gynecol Obstet Hum Reprod. 2021 Sep;50(7):101987. doi: 10.1016/j.jogoh.2020.101987. Epub 2020 Nov 16.

  PMID: 33212324 BACKGROUND

• Pergialiotis V, Prodromidou A, Perrea DN, Doumouchtsis SK. The impact of subcutaneous tissue suturing at caesarean section on wound complications: a meta-analysis. BJOG. 2017 Jun;124(7):1018-1025. doi: 10.1111/1471-0528.14593. Epub 2017 Apr 1.

  PMID: 28176441 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Suture Techniques

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wound Closure Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator, Assistant Professor of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 5, 2026
• Study Start: March 30, 2022
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)