Single-blinded Prospective Trial Comparing Quantitive Blood Loss, Operative Time, and Post Operative Pain Using Stratafix Barbed Suture in Cesarian Section to the Use of Traditional Suture Material
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
- 2
- 主要终点
- Blood loss in closure with barbed synthetic suture
研究概览
简要总结
Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.
详细描述
Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.
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
- 年龄范围
- 16 Years 至 50 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.
排除标准
- •General Anesthesia
- •Non-consent to participation
研究组 & 干预措施
Control
Group of patients receiving standard hysterotomy closure with synthetic braided suture
干预措施: Stratafix synthetic barbed suture (Procedure)
Stratfix
group of patients having the hysterotomy incision closed with barbed synthetic suture. Time to closure, blood loss, and postoperative pain
干预措施: Stratafix synthetic barbed suture (Procedure)
结局指标
主要结局
Blood loss in closure with barbed synthetic suture
时间窗: 2 days
monitoring of preoperative and postoperative hemoglobin and hematcrit
次要结局
- Post operative pain after cesarean secton(3 days)
研究者
Russell J. Stankiewicz, MD
Assistant Clinical professor OB/GYN, Family Medicine, The Commonwealth Medical College
Evangelical Community Hospital, Lewisburg, PA
