ArticleTrials2024
Efficacy of the preformulated irrigation solution Bactisure® in acute periprosthetic joint infection debridement surgery: study protocol for a randomized controlled trial.
Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
4 citing papers in PubMed.
- Electrolytic cleaning as a biofilm control strategy on medical implants: mechanisms, evidence and translational perspectives.Frontiers in microbiology · 2026Review
- Review of Recent Advances in Managing Periprosthetic Joint Infection After Total Knee Arthroplasty: DAIR Technique.Orthopedic research and reviews · 2026Review
- Comparing the in Vitro Efficacy of Commonly Used Surgical Irrigants for the Treatment of Implant-Associated Infections.The Journal of bone and joint surgery. American volume · 2025Article
- Article
Corrections and comments
- Erratum issued
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite 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.
methodsProspective 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 registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696 . Registered on December 19, 2023.
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