Preformulated Antibiofilm Irrigation Does Not Improve Outcomes in Dair for Acute Periprosthetic Joint Infection: A Randomized Controlled Trial

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Aim To evaluate the clinical effectiveness of a preformulated antibiofilm irrigation solution compared with normal saline in patients with acute hip or knee periprosthetic joint infection (PJI) treated with debridement, antibiotics, irrigation, and implant retention (DAIR). Methods We conducted a single-centre randomized controlled trial including patients with acute postoperative or hematogenous hip or knee PJI treated with DAIR between December 2022 and December 2024. Patients were randomized (1:1) to irrigation with normal saline or a preformulated antibiofilm solution*. The primary endpoint was infection control at 12 months. Secondary objectives included analysis of failure patterns and identification of factors associated with treatment outcomes. The primary analysis followed a modified intention-to-treat (mITT) approach, including only patients with confirmed PJI and available follow-up. Results Of 56 patients initially enrolled, 48 were included in the final analysis (24 per group). Two patients were lost to follow-up due to deaths unrelated to PJI, and six were excluded because PJI diagnosis could not be confirmed according to predefined criteria. Baseline characteristics were comparable, except for a higher proportion of anticoagulant therapy in the group with a preformulated antibiofilm solution* (58.3% vs 25%; p=0.039). The overall success rate was 56.25% (27/48), with no significant difference between groups (saline 54.16% vs preformulated antibiofilm solution* 58.33%; p=1.000). Kaplan–Meier analysis showed that most failures occurred within the first six weeks after DAIR, with no differences between groups (p=0.638). No adverse events related to the preformulated antibiofilm solution* were identified. Primary total hip arthroplasty was independently associated with a lower risk of failure (OR 0.12; 95% CI 0.01–0.97; p=0.047). Among failures requiring repeat debridement, most recurrences were relapses with the same pathogen. Conclusions In this randomized controlled trial, the use of a preformulated antibiofilm irrigation solution did not improve infection control compared with normal saline in DAIR for acute or hematogenous PJI. Failures occurred early and were predominantly due to relapse with the initial pathogen. * Bactisure®