Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 12
- 主要终点
- Superficial surgical site infection (SSI)
研究概览
简要总结
Research hypothesis:
Does delayed primary wound closure after appendectomy in adults with complicated appendicitis reduce postoperative superficial surgical site infection compare to primary wound closure.
Study design:
This study is a multicenter randomized controlled trial of delay versus primary wound closure in complicated appendicitis.
Setting:
Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira Hospital, and Pathumthani Hospital
Participants:
Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as gangrenous or ruptured appendicitis.
Outcome:
Superficial surgical site infection
Period of study:
August 2012 - August 2014
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Superficial surgical site infection (SSI)
时间窗: within 1 month after operation
Superficial SSI, which will be diagnosed using the Center for Disease Control (CDC) criteria as follows: * Infection within 30 days and * Involves only skin and subcutaneous tissue of the incision and * One of the following: * Purulent drainage, * organism isolated from culture of fluid or tissue * one of the following signs or symptoms: * pain or tenderness; * localized, swelling, redness, or * heat And the superficial incision is deliberately opened by surgeon
次要结局
- postoperative pain(within 3 days after operation)
- Quality of life(1 month after operation)
- Cost of treatment(1 month after operation)
研究者
Boonying Siribumrungwong
Section for Clinical Epidemiology and Biostatistics
Ramathibodi Hospital