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

Yuzuncu Yil University

Status: Completed

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

Treatments: Other: Suture technique, Interrupted closure (3 sutures); Other: Suture technique, Continuous non-locking closure

Study type: Interventional

Funder types: Other

Identifiers

NCT07451275

YuzuncuYılUniversity_CS_Suture

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Subcutaneous Closure (No Suturing)

No Intervention group

Description:

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

Interrupted Subcutaneous Closure (Three Interrupted Sutures)

Experimental group

Description:

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

Treatment:

Other: Suture technique, Interrupted closure (3 sutures)

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

Experimental group

Description:

Participants undergo elective cesarean delivery with single-layer subcutaneous tissue suturing using a continuous, non-locking suture technique prior to skin closure

Treatment:

Other: Suture technique, Continuous non-locking closure