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

Last updated: January 14, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Not Recruiting

Phase

1

Condition

Osteoarthritis

Treatment

Conventional

Povidone iodine

Vancomycin powder

Clinical Study ID

NCT04075526
19-00851
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient has no open wounds on operative leg

  • Patient is scheduled to undergo elective primary and revision total jointarthroplasty for posttraumatic, osteoarthritis, avascular necrosis, and/orinflammatory 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 determinedby the presence of one or more of the following characteristics: BMI >35, activesmoker, ASA ≥ 3, immunosuppressed (i.e. being treated with chemotherapy, diagnosisof HIV, diagnosis of HCV, being treated with chronic steroids, patients withinflammatory arthropathies), diagnosis with diabetes mellitus, establishedcolonization with S. aureus, or any patient undergoing revision TJA

  • Patient understand the risks and benefits associated with TJA and willing tocooperate and follow study protocol and visit schedule

Exclusion

Exclusion Criteria:

  • Patient is pregnant

  • Patient is unable to provide written consent

  • Patient has psychiatric disorder that precludes safe study participation or thatnecessitates confinement in a custodial environment at home or in a chronic carefacility

  • Patient does not have the mental capacity to participate and comply with the studyprotocol

  • 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

Study Design

Total Participants: 2129
Treatment Group(s): 3
Primary Treatment: Conventional
Phase: 1
Study Start date:
October 01, 2019
Estimated Completion Date:
January 01, 2026

Study 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.

Connect with a study center

  • Loma Linda University School of Medicine

    Loma Linda, California 92350
    United States

    Site Not Available

  • Eisenhower Health

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Centura Health

    Denver, Colorado 80210
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • New England Baptist Hospital

    Boston, Massachusetts 02120
    United States

    Site Not Available

  • The Orthopedic Institute of New Jersey

    Sparta, New Jersey 07871
    United States

    Site Not Available

  • Columbia

    New York, New York 10036
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • New York University Dept of Orthopedic Surgery

    New York, New York 10003
    United States

    Site Not Available

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Site Not Available

  • Cleveland Clinic Ohio

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Inova Mount Vernon Hospital

    Alexandria, Virginia 22306
    United States

    Site Not Available

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