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

  • STATUS
    Recruiting
  • End date
    Jan 14, 2025
  • participants needed
    10000
  • sponsor
    NYU Langone Health
Updated on 14 May 2021
avascular necrosis
joint reconstruction

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.

Description

The study seeks to define the potential benefits that an additional prophylactic protocol involving the use of povidone iodine and vancomycin powder on the incidence of PJI in high risk TJA patients. The potential benefits of these interventions are significant both from the perspective of reducing morbidity and mortality for the patient, and from a cost-effectiveness and value-based perspective. To this end, our study seeks to assess the direct and indirect costs associated with the treatment and control groups. We anticipate that the administration of a VPIP protocol will both reduce the incidence of PJI in high risk groups relative to the control arm and will demonstrate added value from a cost-effectiveness perspective.

This study looks to examine off-label use of Vancomycin Powder and Povidone Iodine 10% solution. Both products are lawfully marketed in the United States. This study is not intended to be reported to the FDA as a well-controlled study in support of a new indication and there is no intent to use it to support any other significant change in the labeling or advertising of either drug.

This study does not involve a route of administration, dose, patient population, or other factor that significantly increased the risk (or decreases the acceptability of the risk) associated with the use of the drug product. The routes and dosages being tested in this protocol are part of standard clinical care in most total joint arthroplasty surgeries.

Details
Condition Arthritis, Osteoarthritis, Arthritis and Arthritic Pain, Arthritis and Arthritic Pain (Pediatric), degenerative arthritis
Treatment conventional, Povidone Iodine, Vancomycin powder
Clinical Study IdentifierNCT04075526
SponsorNYU Langone Health
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

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
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