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临床试验/NCT05090176
NCT05090176Unknown不适用

Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia

Universiti Sains Malaysia2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年11月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
试验地点
2
主要终点
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia

研究概览

简要总结

To determine efficacy of using 3 minutes povidone-soaked suture in reducing surgical site infection during wound closure in elective surgery.

详细描述

Participant recruitment and randomisation based on eligibility based on CONSORT.

Patient will get either package A or B which determine whether they are getting povidone-soaked suture or ordinary suture during wound closure.

Postoperative, follow up on D10 and D30 of patient well being and signs and symptoms of surgical site infection

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than 12 years old
  • Clean surgery or Clean- contaminated surgery
  • Elective surgery

排除标准

  • Age less than 12 years old
  • Contaminated wound
  • Dirty wound
  • Allergy to povidone-iodine
  • Laparoscopic
  • Emergency surgery

结局指标

主要结局

Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia

时间窗: 6 months

There is difference of outcome using povidone-soaked suture and ordinary suture. In this study, our hypothesis the suture with povidone-soaked will reduce the SSIs rate during closure and it will be assessed on day 10 and day 30 post-operative. Few measurement are used in detection of SSI based on clinical and biochemical measurement such as signs of inflammation and total white cell count.

次要结局

  • Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SITI HAFZAN

Principle investigator

Universiti Sains Malaysia

研究点 (2)

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