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Infection Prophylaxis with Vancomycin + Povidone Iodine for Post-Surgical Joint Infections

Phase 1
Waitlist Available
Led By Ran Schwarzkopf, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient does not have active infection on the operative leg, the operative joint
Patient is scheduled to undergo elective primary and revision total joint arthroplasty for posttraumatic, osteoarthritis, avascular necrosis, and/or inflammatory arthritis
Must not have
Patient does not have the mental capacity to participate and comply with the study protocol
Patient has active infections in the operative leg/joint
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare different ways to prevent joint infections after surgery.

Who is the study for?
This trial is for adults at high risk of infection after joint replacement surgery due to factors like obesity, smoking, weak immune system (from conditions like HIV or treatments like chemotherapy), diabetes, known S. aureus colonization, or needing a revision of their joint surgery. They must understand the procedure and follow the study plan without any active infections in the leg/joint or severe mental incapacity.
What is being tested?
The study tests if applying Vancomycin powder or dilute Povidone Iodine during surgery can prevent acute infections post-joint replacement. It's a controlled comparison with four groups: one standard care and three different interventions, assigned randomly to participants across multiple centers.
What are the potential side effects?
Potential side effects may include allergic reactions to Vancomycin or Povidone Iodine such as skin rash, itching, difficulty breathing; irritation at the surgical site; and possibly systemic effects if absorbed into the bloodstream.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have an infection in the leg or joint that will be operated on.
Select...
I am scheduled for joint replacement surgery due to arthritis or injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and follow the study's requirements.
Select...
I have an active infection in my leg or joint where surgery is planned.
Select...
I have been diagnosed with severe dementia.
Select...
I have had a joint infection before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of periprosthetic infection (PJI) after elective total joint arthroplasty.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Povidone iodine and vancomycin powderExperimental Treatment2 Interventions
Group II: Povidone iodine aloneExperimental Treatment1 Intervention
Group III: Vancomycin powder aloneActive Control1 Intervention
Group IV: ConventionalActive Control1 Intervention
neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Povidone iodine
2007
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,413 Previous Clinical Trials
853,643 Total Patients Enrolled
17 Trials studying Osteoarthritis
1,984 Patients Enrolled for Osteoarthritis
Ran Schwarzkopf, MDPrincipal InvestigatorNYU Langone
4 Previous Clinical Trials
538 Total Patients Enrolled
1 Trials studying Osteoarthritis
230 Patients Enrolled for Osteoarthritis

Media Library

Conventional Clinical Trial Eligibility Overview. Trial Name: NCT04075526 — Phase 1
Osteoarthritis Research Study Groups: Vancomycin powder alone, Conventional, Povidone iodine and vancomycin powder, Povidone iodine alone
Osteoarthritis Clinical Trial 2023: Conventional Highlights & Side Effects. Trial Name: NCT04075526 — Phase 1
Conventional 2023 Treatment Timeline for Medical Study. Trial Name: NCT04075526 — Phase 1
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04075526 — Phase 1
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