OsteoarthritisPhase 1NCT04075526
Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
A Phase 1 study testing Povidone iodine, Vancomycin powder and Conventional in people with Osteoarthritis, run by NYU Langone Health at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Povidone iodine, Vancomycin powder and Conventional
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,129 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Oct 2019to 13 Dec 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
New England Baptist Hospital
Boston, Massachusetts, 02120
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Ohio
Cleveland, Ohio, 44195
Centura Health
Denver, Colorado, 80210
New York University Dept of Orthopedic Surgery
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
Columbia
New York, New York, 10036
Eisenhower Health
Rancho Mirage, California, 92270
St. Francis Hospital
Roslyn, New York, 11576
The Orthopedic Institute of New Jersey
Sparta, New Jersey, 07871
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
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.
Read the 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
- Being tested
- Povidone iodine, Vancomycin powder, Conventional
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone iodineDrug
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 powderDrug
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
ConventionalOther
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
| Study group | Role | What they receive |
|---|---|---|
| Povidone iodine and vancomycin powder | Experimental | Not described Receives: Drug: Povidone iodine; Drug: Vancomycin powder |
| Povidone iodine alone | Experimental | Not described Receives: Drug: Povidone iodine |
| Vancomycin powder alone | Active comparator | Not described Receives: Drug: Vancomycin powder |
| Conventional | Active comparator | neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Oct 2019
- Primary completion1 Jan 2024
- Study completion13 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ran Schwarzkopf, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075526
- Sponsor's protocol ID
- 19-00851
- Status last verified
- Jan 2026
- First submitted
- 29 Aug 2019
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Saba BV; VPIP Study Group; Higuera-Rueda CA, Dundon J, Cooper HJ, Dennis DA, Long WJ, Chen AF, Schwarzkopf R. The Three-Month Wound Complication and Infection Rates After Vancomycin Powder and Dilute Povidone-Iodine Lavage for Infection Prophylaxis in High-Risk Total Joint Arthroplasty: A Multicenter Randomized Controlled Trial. J Arthroplasty. 2025 Sep;40(9 Suppl 1):S487-S494. doi: 10.1016/j.arth.2025.04.084. Epub 2025 May 9.
PubMed 40349869