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临床试验/NCT03170843
NCT03170843已完成不适用

Randomized Controlled Trial to Evaluate the Effectiveness and Efficacy of a Sterile Circular Polyethylene Drape Compared to Conventional Surgical Dressing in Prevention of Surgical Site Infection

Saint Vincent's Hospital, Korea21 个研究点 分布在 1 个国家目标入组 457 人开始时间: 2017年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
457
试验地点
21
主要终点
The rate of surgical wound infection

研究概览

简要总结

This study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the rate of surgical site infection in patients who undergo open abdomen surgery for gastrointestinal tract.

详细描述

Participants who are determined to undergo open abdomen surgery will be screening for the eligibility first. If eligible and agreed to participate, each participant will be assigned to either the experimental group or control group based on the electronic randomization. The experimental group will use the plastic ring wound retractor, while the control group will use a conventional surgical pad for wound protection method. Each participant will be blind to the randomization result because he/she will be under general anesthesia. Once the surgery is finished, the patient will be assessed on the surgical wound at postoperative day 1, 7, 14, 30. Two groups will be compared for the surgical wound infection rate.

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
Single (Participant)

盲法说明

Each participant will be under the general anesthesia without knowing which group is assigned to.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age older than 18 years or less than 75 years
  • either elective or emergent surgery for upper GI, small intestine, or colorectal disease
  • open laparotomy
  • the patient who agrees to participate in this trial

排除标准

  • concurrent abdominal wall infection
  • open conversion from laparoscopy
  • poor nutritional status, NRS 2002 score 3
  • combined hepatobiliary operation
  • pregnant or breast-feeding state
  • severe immunosuppression

结局指标

主要结局

The rate of surgical wound infection

时间窗: within 30 days postoperative

The rate of surgical wound infection will be monitored for each group.

次要结局

未报告次要终点

研究者

发起方
Saint Vincent's Hospital, Korea
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyung Jin Kim

Professor

Saint Vincent's Hospital, Korea

研究点 (21)

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