Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
Key facts
- Where
- Boston, Chicago, Cleveland, Denver, New York, Rancho Mirage, Roslyn, Sparta, and Weston, United StatesSee the 14 sites
- Phase
- Phase 1
Where in United States
- Boston Medical CenterBoston, United StatesNo longer taking part
- Brigham and Women's HospitalBoston, United StatesNo longer taking part
- New England Baptist HospitalBoston, United StatesNo longer taking part
- Rush University Medical CenterChicago, United StatesNo longer taking part
- Cleveland Clinic OhioCleveland, United StatesNo longer taking part
- Centura HealthDenver, United StatesNo longer taking part
- ColumbiaNew York, United StatesNo longer taking part
- Hospital for Special SurgeryNew York, United StatesNo longer taking part
- Mount Sinai HospitalNew York, United StatesNo longer taking part
- New York University Dept of Orthopedic SurgeryNew York, United StatesNo longer taking part
- Eisenhower HealthRancho Mirage, United StatesNo longer taking part
- St. Francis HospitalRoslyn, United StatesNo longer taking part
- The Orthopedic Institute of New JerseySparta, United StatesNo longer taking part
- Cleveland Clinic FloridaWeston, United StatesNo longer taking part
Trial details
- Who runs it
- NYU Langone Health
- Trial code
- NCT04075526
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Suspicion of illicit drug abuse by patient; History of prior native septic joint arthritis; No planned procedure within 90 days of surgery; 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 has active infections in the operative leg/joint; Patient has severe dementia; Patient is pregnant; Patient is unable to provide written consent; Patient does not have the mental capacity to participate and comply with the study protocol; ASA score of 5 \& 6.