Surgical Site Infections: a Cluster-randomized, Cross-over Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3,317
- 试验地点
- 1
- 主要终点
- Surgical Site Infection
研究概览
简要总结
Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main outcome measure.
A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital
排除标准
- •All patients undergoing contaminated, dirty surgeries and those undergoing repeat procedures within 2 weeks after the initial surgical intervention.
- •Patients who did not consent to participate in the study
研究组 & 干预措施
Plain soap and water
Surgical hand preparation with plain soap and water
干预措施: Plain soap and water (PSW) (Other)
Alcohol based hand rubs
Surgical hand preparation with alcohol based alcohol hand rub
干预措施: Alcohol-based hand rub (ABHR) (Other)
结局指标
主要结局
Surgical Site Infection
时间窗: 30 days post-operatively
255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).
次要结局
- Cost of Hand Preparation Agent(30 days)