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

NCT ID: NCT04075526

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 2129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2026-01-01

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.

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Povidone iodine and vancomycin powder

Group Type: EXPERIMENTAL

Povidone iodine

Intervention Type: DRUG

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.

Vancomycin powder

Intervention Type: DRUG

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

Povidone iodine alone

Group Type: EXPERIMENTAL

Povidone iodine

Intervention Type: DRUG

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.

Vancomycin powder alone

Group Type: ACTIVE_COMPARATOR

Vancomycin powder

Intervention Type: DRUG

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

Conventional

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

Group Type: ACTIVE_COMPARATOR

Conventional

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ran Schwarzkopf, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Locations

Eisenhower Health

Rancho Mirage, California, United States

Centura Health

Denver, Colorado, United States

Cleveland Clinic Florida

Weston, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

New England Baptist Hospital

Boston, Massachusetts, United States

The Orthopedic Institute of New Jersey

Sparta, New Jersey, United States

New York University Dept of Orthopedic Surgery

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Columbia

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Cleveland Clinic Ohio

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

19-00851

Identifier Type: -

Identifier Source: org_study_id