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临床试验/NCT05330650
NCT05330650已完成4 期

Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Randomized Controlled Study

Tunis University1 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
318
试验地点
1
主要终点
Incidence of surgical site infection

研究概览

简要总结

A prospective comparative randomized blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over an eight-month period between November 2020 and June 2021.

The aim of this study is to evaluate effectiveness of Triclosan coated suture use in obstetrical surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with indicated cesarean delivery and who have signed a written consent.

排除标准

  • Cases with incomplete follow up
  • Breach of operative protocol

研究组 & 干预措施

Triclosan coated suture

Active Comparator

干预措施: Coated Vicryl+ (Drug)

Non coated suture

Active Comparator

干预措施: Vicryl (Drug)

结局指标

主要结局

Incidence of surgical site infection

时间窗: 30 days

次要结局

  • Health care costs attributable to surgical site infection(30 days)
  • Wound healing time(30 days)

研究者

发起方
Tunis University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hajer BETTAIEB

Assistant professor

Tunis University

研究点 (1)

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