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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

2,129

Participants

Timeline

Start Date

October 1, 2019

Primary Completion Date

January 1, 2024

Study Completion Date

January 1, 2026

Conditions
Osteoarthritis
Interventions
DRUG

Povidone iodine

To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.

DRUG

Vancomycin powder

2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia

OTHER

Conventional

No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort

Trial Locations (14)

10003

New York University Dept of Orthopedic Surgery, New York

10021

Hospital for Special Surgery, New York

10029

Mount Sinai Hospital, New York

10036

Columbia, New York

11576

St. Francis Hospital, Roslyn

33331

Cleveland Clinic Florida, Weston

44195

Cleveland Clinic Ohio, Cleveland

60612

Rush University Medical Center, Chicago

80210

Centura Health, Denver

92270

Eisenhower Health, Rancho Mirage

02115

Brigham and Women's Hospital, Boston

02118

Boston Medical Center, Boston

02120

New England Baptist Hospital, Boston

07871

The Orthopedic Institute of New Jersey, Sparta

All Listed Sponsors
lead

NYU Langone Health

OTHER