Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, controlled, open label, parallel four-arm design, multi-center study to compare different intraoperative interventions in the prevention of acute PJI development.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Treatments: Cadexomer iodine; Iodine; Povidone; Povidone-Iodine; Vancomycin

Criteria

Inclusion Criteria:

• Patient has no open wounds on operative leg

• Patient is scheduled to undergo elective primary and revision total joint arthroplasty for posttraumatic, osteoarthritis, avascular necrosis, and/or inflammatory arthritis

• Patient does not have active infection on the operative leg, the operative joint

• Patient are identified as high risk for the development of PJI which is determined by the presence of one or more of the following characteristics: BMI >35, active smoker, ASA ≥ 3, immunosuppressed (i.e. being treated with chemotherapy, diagnosis of HIV, diagnosis of HCV, being treated with chronic steroids, patients with inflammatory arthropathies), diagnosis with diabetes mellitus, established colonization with S. aureus, or any patient undergoing revision TJA

• Patient understand the risks and benefits associated with TJA and willing to cooperate and follow study protocol and visit schedule

Exclusion Criteria:

• Patient is pregnant

• Patient is unable to provide written consent

• Patient has psychiatric disorder that precludes safe study participation or that necessitates confinement in a custodial environment at home or in a chronic care facility

• Patient does not have the mental capacity to participate and comply with the study protocol

• Patient has active infections in the operative leg/joint

• Patient has severe dementia

• Suspicion of illicit drug abuse by patient

• ASA score of 5 & 6

• History of prior native septic joint arthritis

• No planned procedure within 90 days of surgery