Comparison of Barbed and Conventional Sutures in Adhesion Formation Following Cesarean Section; a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Adhesions formation rate
研究概览
简要总结
The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with more postoperative adhesions compared with conventional sutures or not.
详细描述
The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with an increase in the rate of postoperative adhesions compared with conventional sutures or not. Primigravida patients undergoing transverse lower segment cesarean section will be included in the study.Cesarean section incision will be closed with double layers of continuous barbed or conventional sutures.Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primigravida patients undergoing transverse lower segment cesarean section
排除标准
- •Previous laparotomies
- •Postoperative fever
- •Patients with preterm pregnancies or in labor
研究组 & 干预措施
Barbed suture ( STRATAFIX™ )
Cesarean section incision is closed using barbed sutures
干预措施: Barbed suture ( STRATAFIX™ ) (Device)
Conventional suture (VICRYL™)
Cesarean section incision is closed using conventional sutures
干预措施: Conventional suture (VICRYL™) (Device)
结局指标
主要结局
Adhesions formation rate
时间窗: Through study completion, an average of 3 year
Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.
次要结局
未报告次要终点