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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04075526
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NYU Langone Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

William Long
Principal Investigator Affiliation NYU Langone
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Povidone iodine and vancomycin powder

Experimental: Povidone iodine alone

Active Comparator: Vancomycin powder alone

Active Comparator: Conventional

neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation

Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Eisenhower Health, Rancho Mirage, California

Status

Recruiting

Address

Eisenhower Health

Rancho Mirage, California, 92270

Site Contact

Erik Schnaser, MD

[email protected]

909-558-4729

Cleveland Clinic Florida, Weston, Florida

Status

Not yet recruiting

Address

Cleveland Clinic Florida

Weston, Florida, 33331

Site Contact

Carlos Higuera, MD

[email protected]

954-659-5000

Rush University Medical Center, Chicago, Illinois

Status

Not yet recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Site Contact

Brett Levine, MD

[email protected]

877-632-6637

Brigham and Women's Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Antonia Chen

[email protected]

617-732-5500

Boston Medical Center, Boston, Massachusetts

Status

Not yet recruiting

Address

Boston Medical Center

Boston, Massachusetts, 02118

Site Contact

Michael Kain, MD

[email protected]

781-744-5100

New England Baptist Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

New England Baptist Hospital

Boston, Massachusetts, 02120

Site Contact

Eric Smith, MD

[email protected]

617-754-5000

New York, New York

Status

Recruiting

Address

New York University Dept of Orthopeadic Surgery

New York, New York, 10003

Site Contact

William Long, MD

[email protected]

646-293-7515

Hospital for Special Surgery, New York, New York

Status

Not yet recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Jonathan Vigdorchik

[email protected]

212-606-1992

Mount Sinai Hospital, New York, New York

Status

Not yet recruiting

Address

Mount Sinai Hospital

New York, New York, 10029

Site Contact

Bill Hamilton, MD

[email protected]

212-241-6500

Columbia, New York, New York

Status

Not yet recruiting

Address

Columbia

New York, New York, 10036

Site Contact

John Cooper, MD

[email protected]

212-305-4565

Cleveland Clinic Ohio, Cleveland, Ohio

Status

Not yet recruiting

Address

Cleveland Clinic Ohio

Cleveland, Ohio, 44195

Site Contact

Nicolas Piuzzi, MD

[email protected]

216-444-2200

Inova Mount Vernon Hospital, Alexandria, Virginia

Status

Not yet recruiting

Address

Inova Mount Vernon Hospital

Alexandria, Virginia, 22306

Site Contact

Robert Sershon, MD

[email protected]

703-619-4400