Efficacy of the preformulated irrigation solution Bactisure® in acute periprosthetic joint infection debridement surgery: study protocol for a randomized controlled trial.

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696 . Registered on December 19, 2023.