Orthopaedic Surgery Department, Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona (UAB), Barcelona, Spain.
Department of Surgery, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
Trials. 2024 Nov 16;25(1):775. doi: 10.1186/s13063-024-08637-1.
Despite significant progress in orthopaedic surgery, the prevalence of periprosthetic joint infections (PJIs) remains persistent, and future increases are expected due to the increasing number of joint arthroplasties. PJIs are intricately connected to biofilm-producing bacteria, which encase infected prostheses, impairing the effectiveness of antibiotics and the immune system. Acute PJIs with immature biofilms are traditionally managed with debridement, antibiotics, and implant retention (DAIR). However, to date, there has not been a conclusive direct clinical comparison (in vivo) demonstrating the superiority of one irrigation solution over others. Recently, there has been a growing interest in irrigation solutions with antibiofilm properties demonstrated in in vitro studies, exemplified by the preformulated Bactisure® irrigation solution, which contains ethanol, acetic acid, sodium acetate, benzalkonium chloride, and sterile water. The main objective of this study was to evaluate the effectiveness (infection cure rate) of preformulated Bactisure® irrigation solution in vivo compared with saline solution in a control group of patients with acute knee and/or hip periprosthetic infections treated with DAIR.
Prospective single-centre randomized controlled trial involving patients with acute haematogenous PJI who received standard DAIR surgery from December 2022 to December 2024. The type of irrigation solution used during surgery will include two groups allocated at a 1:1 ratio: a control group (n = 25) with saline solution and an experimental group (n = 25) receiving the Bactisure® preformulated solution. The sample size was calculated based on an expected reduction in reinfection rates from 45% in the control group to 10% in the experimental group. Data on baseline patient characteristics, clinical and radiological information, and healthcare questionnaires will be recorded. All patients will be followed for minimum of 12 months. The infection cure rate at 1 year will be the primary outcome.
This study is the first to compare the effectiveness of preformulated Bactisure® irrigation solution with that of saline solution in real clinical practice (in vivo) in patients with acute knee and/or hip periprosthetic infections treated with DAIR. Our main hypothesis is that, compared with saline solution, Bactisure® provides a better infection cure rate at 1 year post-DAIR.
International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696 . Registered on December 19, 2023.
尽管矫形外科取得了重大进展，但人工关节周围感染（PJI）的患病率仍然居高不下，并且由于关节置换手术数量的增加，预计未来还会进一步增加。PJI 与产生生物膜的细菌密切相关，这些细菌会包裹感染的假体，从而降低抗生素和免疫系统的有效性。传统上，对于急性、生物膜不成熟的 PJI，采用清创术、抗生素和保留植入物（DAIR）进行治疗。然而，迄今为止，还没有一项具有定论的直接临床比较（体内）证明一种冲洗液优于另一种冲洗液。最近，人们对具有体外研究证实的抗生物膜特性的冲洗液越来越感兴趣，预成型的 Bactisure®冲洗液就是一个例子，它含有乙醇、乙酸、醋酸钠、苯扎氯铵和无菌水。本研究的主要目的是评估预成型的 Bactisure®冲洗液与生理盐水相比，在接受 DAIR 治疗的急性膝关节和/或髋关节假体周围感染患者中的体内（感染治愈率）效果。
这是一项前瞻性单中心随机对照试验，纳入了 2022 年 12 月至 2024 年 12 月期间接受标准 DAIR 手术的急性血源性 PJI 患者。术中使用的冲洗液将包括两组，按 1:1 比例分配：对照组（n=25）使用生理盐水，实验组（n=25）使用 Bactisure®预成型溶液。根据对照组 45%的再感染率降低至实验组 10%的预期，计算了样本量。将记录基线患者特征、临床和影像学信息以及医疗保健问卷的数据。所有患者将至少随访 12 个月。1 年时的感染治愈率将作为主要结局。
本研究是首次在接受 DAIR 治疗的急性膝关节和/或髋关节假体周围感染患者中，比较预成型的 Bactisure®冲洗液与生理盐水在真实临床实践（体内）中的效果。我们的主要假设是，与生理盐水相比，Bactisure®在 DAIR 后 1 年时提供更好的感染治愈率。
国际标准随机对照试验编号（ISRCTN）：https://doi.org/10.1186/ISRCTN10873696。于 2023 年 12 月 19 日注册。
