跳至主要内容
临床试验/NCT02517710
NCT02517710已完成不适用

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

Evangelical Community Hospital, Lewisburg, PA2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年4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
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

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

Placebo Comparator

Group of patients receiving standard hysterotomy closure with synthetic braided suture

干预措施: Stratafix synthetic barbed suture (Procedure)

Stratfix

Experimental

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

发起方
Evangelical Community Hospital, Lewisburg, PA
申办方类型
Other
责任方
Principal Investigator
主要研究者

Russell J. Stankiewicz, MD

Assistant Clinical professor OB/GYN, Family Medicine, The Commonwealth Medical College

Evangelical Community Hospital, Lewisburg, PA

研究点 (2)

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