Cheetah - a Cluster Randomized Trial of Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection (SSI). A Trial in Low and Middle Income Countries (LMICs) and A Trial in High Income Countries (HICs)
试验速览
- 阶段
- 不适用
- 入组人数
- 12,800
- 主要终点
- Surgical Site Infection (SSI) at 30-days post-surgery
研究概览
简要总结
To assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection
详细描述
Internal Pilot
The aim of the 12-month internal pilot is to assess:
- whether hospitals adhere to their allocation
- what proportion of patients who are eligible for ChEETAh can be followed up successfully at 30 days after their surgery
Main Study
To assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection at 30-days post-surgery for patients undergoing clean-contaminated, contaminated or dirty abdominal surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The Randomisation is at the hospital level and hospitals will be randomised to the intervention (of separating sterile surgical instruments and gloves at the time of wound closure). Patients will not be made aware of the hospital/theatre randomisation, as patients would also not be aware of the specifics of any operation
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Countries: LMICs defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list where there are at least 4 eligible hospitals per country in HIC-CHEETAH protocol (HICs are those that do not appear on the Organisation for Economic Co-operation and Development's Official Development Assistance (ODA) list
- •Hospitals (clusters): in LMICs where glove and instrument change is not currently routine hospital practice
- •Participants: Patients undergoing abdominal surgery who satisfy the following criteria are eligible:
- •Emergency (surgery on an unplanned admission) or elective (surgery on a planned admission)
- •Intraoperative finding of clean-contaminated, contaminated or dirty surgery
- •with at least one abdominal incision that is ≥5cm
- •Aged 16 years and over on the day of surgery (applicable to HIC-CHEETAH protocol only)
- •Participant
排除标准
- •Patients undergoing caesarean section
研究组 & 干预措施
Intervention
Change of gloves and use of separate, sterile instruments before closing the abdominal wall
干预措施: Change of gloves and sterile instruments (Procedure)
Current routine hospital practice
No change of gloves or use of separate, sterile instruments before closing the abdominal wall
结局指标
主要结局
Surgical Site Infection (SSI) at 30-days post-surgery
时间窗: 30-days post-surgery
The Centre for Disease Control (CDC) definition will be used in ChEETAh to identify deep incisional or superficial incisional SSIs
次要结局
- Length of hospital stay(Length of hospital stay for the index operation and assessed at the point of discharge up to 30 days)
- Return to normal activities e.g (work, school, or family duties)(The assessment will be made up to 30-days from the index operation.)
- SSI before discharge from hospital(up to 30 days)
- Re-admission(within 30-days post-surgery)
- Death(within 30 days post-surgery)