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
- 7
- 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
- •Adult patients age 18 years or older
- •Have been diagnosed as gangrenous or ruptured appendicitis base on clinical criteria with the following conditions
- •a.Gangrenous appendicitis i.Erythematous or swelling of appendix and ii.Appearance of necrotic wall (dark, grayish color) b.Ruptured appendicitis i. Erythematous or swelling of appendix and ii.Appearance of hole in an appendix or iii.Rupture of appendix during a procedure c.Appearance of frank pus
- •Non-immunocompromised hosts which include
- •History of end-stage renal disease (ESRD)
- •History of autoimmune disease (SLE)
- •Taking immunosuppressive agents (e.g, steroids, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil)
- •Cirrhosis with ascites
- •Morbid obesity (BMI > 40 kg/m2)
- •Non-pregnant women
- •Willing to participate and provide written informed consent
排除标准
- 未提供
研究组 & 干预措施
Primary wound closure
A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.
干预措施: Primary wound closure (Procedure)
Delayed primary wound closure
A wound will be left open with saline-soaked gauze packing after the operative procedure and will be sutured around day 3 to 7 after operation
干预措施: Primary wound closure (Procedure)
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