预制灌溶液Bactisure®在急性周围假肢关节感染脱bridement手术中的有效性:随机对照试验的研究协议
Rafael Oleo-Taltavull1,2,3, Matías Vicente Gomà-Camps4,5,6,7, Nayana Joshi Jubert4,5,7,8
1Orthopaedic Surgery Department, Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona (UAB), Barcelona, Spain. rafael.oleo@vallhebron.cat.
Trials
|November 16, 2024
概括
这项研究将Bactisure®灌液与盐水进行比较,用于治疗经过脱bridement,抗生素和植入物保留 (DAIR) 手术后的急性周围假肢关节感染 (PJIs). 假设Bactisure®可以提高感染治愈率,而不是盐水.
科学领域:
- 整形外科手术 整形外科手术
- 传染性疾病 传染性疾病
- 生物材料科学 生物材料科学
背景情况:
- 周围假肢关节感染 (PJIs) 是关节关节整形术的持续并发症,通常涉及具有挑战性的生物膜.
- 目前的治疗方法,如除菌,抗生素和植入物保留 (DAIR),对成熟的生物膜有局限性.
- 正在研究具有抗菌膜特性的新型灌解决方案,以改善PJI管理.
研究的目的:
- 与盐水相比,评估预制 Bactisure®灌溶液的体内有效性.
- 为了确定急性膝盖和/或部PJIs的DAIR手术后一年的感染治愈率.
主要方法:
- 一个前性的单中心随机对照试验,比较Bactisure® (实验) 与盐水 (对照).
- 50名急性血源性PJI接受DAIR手术的患者被随机分配 (1:1比).
- 主要结果是手术后12个月感染治愈率.
主要成果:
- 数据收集正在进行中,主要结果 (1年内感染治愈率) 尚未确定.
- 样本大小的计算是基于Bactisure®预期的重感染率的显著降低.
结论:
- 这项试验代表了Bactisure®灌溶液与急性PJI治疗DAIR的盐水之间的第一个体内比较.
- 该研究假设,Bactisure®将在一年后与盐水相比,显示出更高的感染治愈率.
- 结果将提供关于抗菌膜灌溶液在PJI管理中的疗效的关键临床数据.
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