At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
In Brief
A Phase 1 clinical trial evaluating Povidone iodine, Vancomycin powder, and 1 other intervention for Osteoarthritis. Completed, enrolled 2,129 participants across 14 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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
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