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

NCT04075526 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 19-00851
• Study Type: interventional
• Target: 2,129
• Locations: 1 country
• Sites: 14

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Povidone iodine and vancomycin powder

EXPERIMENTAL

Drug: Povidone iodine; Drug: Vancomycin powder

Povidone iodine alone

EXPERIMENTAL

Drug: Povidone iodine

Vancomycin powder alone

ACTIVE COMPARATOR

Drug: Vancomycin powder

Conventional

ACTIVE COMPARATOR

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

Other: Conventional

Interventions

Povidone iodine 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.

Povidone iodine alone; Povidone iodine and vancomycin powder

Vancomycin powder 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 and vancomycin powder; Vancomycin powder alone

Conventional 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

Conventional

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (14)

Eisenhower Health

Rancho Mirage, California, 92270, United States

Location

Centura Health

Denver, Colorado, 80210, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

The Orthopedic Institute of New Jersey

Sparta, New Jersey, 07871, United States

Location

New York University Dept of Orthopedic Surgery

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia

New York, New York, 10036, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Cleveland Clinic Ohio

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Povidone-Iodine; Congresses as Topic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Daniel Waren
• Organization: NYU Langone Health

Daniel.Waren@nyulangone.org

212-598-6245

Study Officials

• Ran Schwarzkopf, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: October 1, 2019
• Primary Completion: January 1, 2024
• Study Completion: December 13, 2025
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Locations

US (14)