在整体关节置换 (PREVENT-iT) 中感染预防新兴新疗法的前性随机评估:可行性和安全性研究
Thomas J Wood1,2, Sameer Parpia3, Isabelle Tate2
1Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada.
JB & JS open access
|September 15, 2025
概括
这项试点研究表明,使用消毒灌液和局部抗生素是一种安全和可行的方法,可以在部和膝关节置换术后预防周围假肢关节感染 (PJIs).
科学领域:
- 整形外科手术 整形外科手术
- 预防传染病 预防传染病
- 临床试验设计 临床试验设计
背景情况:
- 周围假肢关节感染 (PJI) 是整体关节整形术的一个主要并发症,通常需要修复手术.
- 消毒灌和局部抗生素是潜在的PJI预防策略,但高质量的证据有限.
- 需要进行最终的试验,以确定PJI的最佳预防治疗方法.
研究的目的:
- 评估一项大规模随机对照试验的可行性和安全性,研究预防性灌溶液和用于预防PJI的局部抗生素.
- 确定最佳的预防性治疗方案,以减少PJI的发生率.
主要方法:
- 一个随机的3 × 2因数试验试验,涉及5个中心的495名参与者.
- 患者接受了六种治疗之一:波维-,化-葡萄酸盐,或盐水,有或没有万科米.
- 使用九个标准评估可行性,包括招生,治疗管理,数据收集和协议遵守. 通过不良事件发生率来评估安全性.
主要成果:
- 试点试验成功满足了9个可行性标准中的7个,表明为最终试验做好准备.
- 为了治疗污染和患者随访的完整性,需要进行微小的调整.
- 需要重新手术的PJI发生率为1.84%,持续的伤口排水率为1.12%. 没有任何严重的不良事件与治疗相关.
结论:
- 预防性消毒剂灌溶液和局部抗生素是可行的和安全的PJI预防.
- 这些发现支持启动一项最终的大规模随机对照试验 (PREVENT-IT),以优化PJI预防.
- 这项研究有可能对临床实践产生重大影响,并降低全球PJI率.
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