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
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
- 是
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
Hyung Jin Kim
Professor
Saint Vincent's Hospital, Korea
