NCT07451275

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Yuzuncu Yil University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-03-30
• Primary completion: 2022-10-20
• Completion: 2022-10-20
• First posted: 2026-03-05
• Last updated: 2026-03-06

Locations

1 site across 1 country: Turkey (Türkiye)