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

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 Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Povidone iodine; Drug: Vancomycin powder; Other: Conventional

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 2129
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Health
  • Colorado
    • Denver, Colorado, United States, 80210
      • Centura Health
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02120
      • New England Baptist Hospital
  • New Jersey
    • Sparta, New Jersey, United States, 07871
      • The Orthopedic Institute of New Jersey
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10003
      • New York University Dept of Orthopedic Surgery
    • New York, New York, United States, 10036
      • Columbia
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Ohio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Povidone iodine and vancomycin powder	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
Experimental: Povidone iodine alone	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.
Active Comparator: Vancomycin powder alone	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
Active Comparator: Conventional; neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of periprosthetic infection (PJI) after elective total joint arthroplasty.	The definition of periprosthetic infection exists when the following criteria are met: NEW MSIS criteria for PJI: 1 major criteria (2) or 6 minor criteria (6) 26-28; Major Criteria: [1] sinus tract [2] + Cx from 2 separate aspirations; Minor Criteria: [1] ESR >30 mm/hr (1 point), [2] D-dimer >860 ng/mL or CRP >1 mg/dL [2] increased synovial WBC (>3000 cells/microliter) [4] alpha-defensin (signal-to-cutoff ratio>1) [5] leukocyte esterase (++) [6] increased synovial PMNs of >80% [7] synovial CRP >6.9 mg/L	90 Days

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Ran Schwarzkopf, MD, NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Plasma Substitutes; Blood Substitutes; Vancomycin; Povidone-Iodine; Povidone
• Other Study ID Numbers: 19-00851

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes