临床评估的成年人接受选择性手术使用手术内切口伤口灌 (CLEAN伤口):一个随机对照试验的协议
Rachel Roke1, Erin Lillie2, Nick Daneman3,4
1Evaluative Clinical Sciences, Sunnybrook Research Institute, Toronto, Ontario, Canada.
BMJ open
|July 17, 2025
概括
这项研究调查了手术内切口伤口灌,以预防高风险手术中的手术部位感染 (SSI). 结果将确定波维-或盐水灌的有效性,与减少SSI没有灌相比.
科学领域:
- 手术感染预防 手术感染预防
- 临床试验方法论 临床试验方法论
背景情况:
- 手术后的手术部位感染 (SSIs) 影响15-25%的接受中度至高风险手术的患者.
- 术内切口伤口灌是一种减轻SSI的潜在策略.
- 需要进一步的随机对照试验来确定伤口灌的疗效.
研究的目的:
- 评估手术内切口伤口灌在减少SSI方面的有效性.
- 为了比较波维-灌,盐水灌和没有灌作为干预措施.
- 评估二次结果,包括生活质量,发病率,死亡率和医疗保健利用率.
主要方法:
- 一个务实,适应性,参与者和评判者盲目的试验,涉及多达2500名参与者在13个加拿大地点.
- 接受腹部或大腿切口手术的参与者被随机分类.
- 干预措施包括用波维-,盐水或没有灌进行手术内切口伤口灌.
主要成果:
- 主要结局是术后30天内手术部位感染的发生率.
- 二次结果包括30天后的生活质量,90天后的发病率,死亡率和医疗保健利用率.
- 该试验招募了参与者,并已完成招募.
结论:
- 这项试验将提供关键证据,证明手术内切口伤口灌对SSI预防的有效性.
- 结果将为手术伤口管理的临床实践指南提供信息.
- 计划通过出版物,会议演讲和临床试验注册表传播结果.
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