Comparison of No Subcutaneous Closure, Interrupted Closure, and Continuous Non-locking Closure at Elective Cesarean Delivery
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
- 否
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)
Participants undergo elective cesarean delivery with no subcutaneous closure prior to skin closure.
Interrupted Subcutaneous Closure (Three Interrupted Sutures)
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)
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
Metin Ayğar
MD, Principal Investigator, Assistant Professor of Obstetrics and Gynaecology
Yuzuncu Yil University
