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

Completed · Phase 1

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT04075526

Run by

NYU Langone Health

People needed

2129

Starts

2019-10-01

Expected to finish

2025-12-13

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Eisenhower Health — Rancho Mirage, California, United States
• Centura Health — Denver, Colorado, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• New England Baptist Hospital — Boston, Massachusetts, United States
• The Orthopedic Institute of New Jersey — Sparta, New Jersey, United States
• New York University Dept of Orthopedic Surgery — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia — New York, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• Cleveland Clinic Ohio — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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