The Prospective Randomized EValuation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT): Feasibility and Safety Study.

Background: Despite the success of total joint arthroplasty for end-stage hip and knee osteoarthritis, periprosthetic joint infection (PJI) remains a devastating complication and leading cause of revision surgery. Antiseptic irrigation solutions and topical antibiotics are promising and cost-effective strategies for the prevention of PJIs, though high-quality evidence assessing their efficacy is lacking. Therefore, this study investigates the feasibility of conducting a definitive trial to determine the optimal prophylactic treatment of PJIs using various irrigation solutions and topical antibiotics. Methods: Using a simple randomized 3 × 2 factorial trial, patients were randomized across 5 centers to 1 of 6 possible treatments (povidone-iodine, chlorhexidine-gluconate, or saline, with or without vancomycin). Nine criteria were assessed to evaluate feasibility including participant enrollment, administration of treatments, data collection methods, and protocol compliance. Adverse event rates were used to assess trial safety. Secondary outcomes included rates of PJI requiring reoperation and persistent wound drainage (PWD). Results: Four hundred and ninety-five participants were included in the pilot trial. Study participants were 56% female with a mean age of 67 years. Seven of the 9 criteria assessing feasibility indicated the trial was successful and no modifications needed. Two criteria, treatment contamination (8.5%) and completeness of patient follow-up (93.8%), were graded as requiring minor adjustment before conducting the definitive trial. There were 114 serious adverse events; none of which were deemed associated with the treatments. Overall, 9 (1.84%) presented with PJIs requiring reoperation, and 6 patients (1.12%) presented with PWD. Conclusion: This study demonstrates the feasibility and safety of prophylactic irrigation solutions and topical antibiotics. PREVENT-IT has received funding from the Canadian Institutes of Health Research toward the definitive, large, multicenter randomized controlled trial (NCT06126614).Ultimately, findings will directly affect clinical practice with the potential to positively influence global rates of PJI. Level of Evidence: NA.