Primary skin closure versus delayed primary skin closure in reducing Surgical Site Infection in dirty midline abdominal operative wounds - A randomized controlled trialÂ
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- JIPMER
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- -Incidence of surgical site infection and degree of SSI (superficial incisional/ deep incisional) as per the definition of CDC in each group .
研究概览
简要总结
The primary purpose of this study is to find out a better method of skin closure in dirty abdominal wounds with respect to surgical site infection. Surgical site infection is rampant in class 4 dirty abdominal operative wounds. Many interventions have been successfully tried in reducing their incidence including prophylactic antibiotics, depilation of surgical site etc. Recently interest has been in the method of skin closure, where dirty skin wounds are left open for daily sterile dressing until the wound is clean enough to be closed. A few studies conducted in this field yielded results in favour of delayed primary skin closure to primary skin closure. But a meta analyses found heterogeneity in most studies and warranted more studies. The hypothesis of our study was that delayed primary closure is superior to primary closure in reducing surgical site infection in dirty midline laporotomy wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients operated for abdominal conditions in general surgery in which surgical incision falls into class-IV- dirty abdominal wound according to CDC which includes -Operative wound with acute purulent bacterial inflammation or perforated viscus -Operative wound where clean tissue is transected to gain access to a collection of pus -Fecal contamination -Retained devitalized tissue -Traumatic wound with delayed treatment ( after 4 hours) -Traumatic wound from dirty source/ Operative wound dirty -Retained foreign body.
排除标准
- •Patient’s refusal -Patient treated outside before coming to the hospital -Patients requires re-exploration in the same hospital admission -Patients in whom primary rectus closure is not possible or in whom laparostoma is warranted -patient expires before discharge -patient less than 18 years of age.
结局指标
主要结局
-Incidence of surgical site infection and degree of SSI (superficial incisional/ deep incisional) as per the definition of CDC in each group .
时间窗: -during hospital stay | -at discharge | -at first visit
次要结局
- -Length of hospital stay in days(-Postoperative pain: third and fifth postoperative day)