Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture: a Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Time required for uterine closure.
研究概览
简要总结
A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section.
详细描述
A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure will be estimated.These will be the primary outcome measures. The secondary outcome measures will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative infection (endometritis) and wound infection..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant patients with an obstetrical indication for delivery by Cesarean section
排除标准
- •Patients with blood clotting disorders.
研究组 & 干预措施
Stratafix suture
干预措施: Stratafix suture (Device)
Vicryl suture
干预措施: Vicryl suture (Device)
结局指标
主要结局
Time required for uterine closure.
时间窗: From the beginning of first uterine suture till the last suture ending uterine incision complete closure and any additional hemostatic sutures if applicable. The estimated period of time is 8 minutes (average).
Time measured in minutes and seconds
次要结局
- Blood loss during uterine closure(Estimated period of time is 4 days.)
研究者
Leon Grin
Gynecological Doctor
Barzilai Medical Center