跳至主要内容
临床试验/CTRI/2024/11/076107
CTRI/2024/11/076107已完成4 期

Effectiveness of triclosan coated polydioxanone suture in comparison to non coated polydioxanone suture in closure of midline laparotomies in terms of SSI and wound dehiscence a randomized trial.

Rajendra Institute of medical sciences1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2024年11月12日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
154
试验地点
1
主要终点
Incidence of Surgical site infection and wound dehiscence

研究概览

简要总结

This study is a randomised  single blind , parallel group , single centre trial assessing the effectiveness of Triclosan coated polydioxanone suture in comparison to non coated polydioxanone suture in Rajendra institute of Medical Sciences , Ranchi , Jharkhand,  India .  The primary outcome will be to determine the incidence of surgical site infection (SSI)  and wound dehiscence at day 15 . The secondary outcomes are to estimate the risk ratio of SSI and Wound dehiscence at day 15 ; and to estimate the baseline characteristics of patients with midline laparotomies.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing midline laparotomy.
  • Both elective and emergency cases.
  • Those who will be treated at RIMS Ranchi between [study duration].

排除标准

  • Patients who are planned for second look surgery Patients who are immunocompromised or on immunosuppresants .
  • Patients undergoing stoma reversal surgery.

结局指标

主要结局

Incidence of Surgical site infection and wound dehiscence

时间窗: 15 days

次要结局

  • risk ratio of SSI in patients with midline laparotomies.(15 days)
  • To estimate the risk ratio of wound dehiscence in patients with midline laparotomies.(15 days)
  • To estimate the baseline characteristics of patients with midline laparotomies.(15 days)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR PRAGYA SINHA

Rajendra institute of medical sciences

研究点 (1)

Loading locations...

相似试验