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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075526
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Povidone iodine Drug: Vancomycin powder Other: Conventional Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of periprosthetic infection (PJI) after elective total joint arthroplasty. [ Time Frame: 90 Days ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075526


Contacts
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Contact: Daniel Waren 212-598-6245 Daniel.Waren@nyulangone.org

Locations
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United States, California
Eisenhower Health Recruiting
Rancho Mirage, California, United States, 92270
Contact: Erik Schnaser, MD    909-558-4729      
Principal Investigator: Erik Schnaser, MD         
United States, Florida
Cleveland Clinic Florida Not yet recruiting
Weston, Florida, United States, 33331
Contact: Carlos Higuera, MD    954-659-5000    higuerc@ccf.org   
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Brett Levine, MD    877-632-6637    levine.research@rushortho.com   
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Antonia Chen    617-732-5500    afchen@bwh.harvard.edu   
Boston Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Michael Kain, MD    781-744-5100      
New England Baptist Hospital Not yet recruiting
Boston, Massachusetts, United States, 02120
Contact: Eric Smith, MD    617-754-5000      
United States, New York
New York University Dept of Orthopeadic Surgery Recruiting
New York, New York, United States, 10003
Contact: William Long, MD    646-293-7515    William.Long2@nyulangone.org   
Hospital for Special Surgery Not yet recruiting
New York, New York, United States, 10021
Contact: Jonathan Vigdorchik    212-606-1992    VigdorchikJ@hss.edu   
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Bill Hamilton, MD    212-241-6500      
Columbia Not yet recruiting
New York, New York, United States, 10036
Contact: John Cooper, MD    212-305-4565    hjc2008@cumc.columbia.edu   
United States, Ohio
Cleveland Clinic Ohio Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Nicolas Piuzzi, MD    216-444-2200    piuzzin@ccf.org   
United States, Virginia
Inova Mount Vernon Hospital Not yet recruiting
Alexandria, Virginia, United States, 22306
Contact: Robert Sershon, MD    703-619-4400      
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: William Long NYU Langone
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04075526    
Other Study ID Numbers: 19-00851
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Vancomycin
Povidone-Iodine
Povidone
Anti-Bacterial Agents
Anti-Infective Agents
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local