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临床试验/NCT07451275
NCT07451275已完成不适用

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

Yuzuncu Yil University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年3月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Overall wound complications by postoperative day 10

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Suture technique, Interrupted closure (3 sutures) (Other)

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

干预措施: Suture technique, Continuous non-locking closure (Other)

结局指标

主要结局

Overall wound complications by postoperative day 10

时间窗: 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.

次要结局

  • Operative duration(Day of surgery (intraoperative))

研究者

发起方
Yuzuncu Yil University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Metin Ayğar

MD, Principal Investigator, Assistant Professor of Obstetrics and Gynaecology

Yuzuncu Yil University

研究点 (1)

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