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临床试验/NCT02288013
NCT02288013已完成不适用

Uterine Closure at C-section by Stratafix Tissue Control Device: Randomized Case-Control Study

Mohamed Zayed1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年10月1日最近更新:
适应症
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
100
试验地点
1
主要终点
Time needed to close the uterine incision

研究概览

简要总结

Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during suturing.

详细描述

A Randomized prospective case control study to evaluate the surgical outcome of using the new barbed bidirectional tissue controlling device in reducing the time and blood loss at uterine closure during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure is used and the occurrence of any tearing of the uterine muscles at the time closure of the uterine incision will be also studied. These will be the primary outcome measure and the secondary outcome measure will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative fever, and the number of sutures required to close the uterine incision.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •All pregnant patients with an indication for delivery by C section

排除标准

  • •Patient refusing to participate in the study

研究组 & 干预措施

Stratafix Tissue control device

Other

Closure of Uterine incision at C section

干预措施: Closure of uterine incision at C section (Procedure)

Vicryl suture

Other

Closure of uterine incision at C section

干预措施: Closure of uterine incision at C section (Procedure)

结局指标

主要结局

Time needed to close the uterine incision

时间窗: 6 minutes

A model is set to evaluate success and failure according the ime needed to close the uterine incision if more or less than 6 minutes

次要结局

  • blood loss during uterine closure(intraoperative during uterine closure)

研究者

发起方
Mohamed Zayed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Zayed

Professor of Obstetrics and Gynecology Cairo University

Cairo University

研究点 (1)

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