NCT02962011已完成3 期
Randomized Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
Ziv Hospital2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Uterine incision closure time
研究概览
简要总结
This was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Also measured were blood loss during incision closure and the use of additional hemostatic sutures. Informed consent was obtained
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
- Single (Participant)
盲法说明
unblinded
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •elective cesarean
- •elective repeat cesarean
排除标准
- •emergent or urgent cesarean
- •chorioamninitis
- •placental abruption
- •placenta previa or accreta
- •known uterine fibroids
- •women with known medical problems such as coagulopathy
研究组 & 干预措施
Knotless barbed suture
Experimental
干预措施: Knotless barbed suture (Device)
polyglactin 910
Active Comparator
Vicryl
干预措施: polyglactin 910 (Device)
结局指标
主要结局
Uterine incision closure time
时间窗: 5 months
uterine incision closure time
次要结局
- uterine incision blood loss(5 months)
- hemostatic suture use(5 months)
研究者
David Peleg
MD
Ziv Hospital
研究点 (2)
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