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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
1,367 Previous Clinical Trials
837,632 Total Patients Enrolled
17 Trials studying Osteoarthritis
1,996 Patients Enrolled for Osteoarthritis
Ran Schwarzkopf, MDPrincipal InvestigatorNYU Langone
4 Previous Clinical Trials
760 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can more people still join this research project?

"The trial is currently still recruiting patients, according to the information on clinicaltrials.gov. This particular study was originally posted on October 1st, 2019 and updated as recently as February 25th, 2022."

Answered by AI

Does this research opportunity have an age limit?

"As long as they are between 18-100 years old, patients of any age can participate in this trial."

Answered by AI

What are some common off-label uses for Vancomycin powder?

"Vancomycin powder is the standard of care for preparting the periocular region before therapy. Additionally, Vancomycin powder has been shown to be useful in treating other conditions such as irrigation and cdad."

Answered by AI

Has the Vancomycin powder gone through testing by the FDA?

"Since this is a Phase 1 trial, there is only limited data to support the Vancomycin powder's safety."

Answered by AI

Are there any restrictions for who is able to participate in this research project?

"This large-scale clinical trial aims to enroll 10,000 patients aged 18 and 100 who are suffering from arthrosis. Eligible applicants will meet the following high-risk criteria for developing PJI: 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. Additionally, eligible candidates cannot have active infection on the operative leg or joint"

Answered by AI

How many different medical clinics are running this study today?

"There are currently 14 enrolling patients for this trial at locations such as Centura Health in Denver, Boston Medical Center in Chicago and Rush University Medical Center in Sparta. There are also other sites located throughout the country."

Answered by AI

How many individuals are included in this experimental research?

"In order to obtain accurate results, this study requires the participation of 10,000 individuals that meet the pre-specified requirements. Centura Health in Denver and Boston Medical Center in Chicago are two of the many hospitals where patients can take part in this trial."

Answered by AI

Does Vancomycin powder have a long history of being studied in humans?

"The first clinical trial studying vancomycin powder was conducted in 2010 at Sacramento Pediatric Gastroenterology. As of now, there have been a total 234 completed trials and 71 active ones. A high concentration of these active studies are based in Denver, Colorado."

Answered by AI

Who else is applying?

What state do they live in?
Rhode Island
New York
Massachusetts
What site did they apply to?
Cleveland Clinic Florida
New England Baptist Hospital
Other
New York University Dept of Orthopedic Surgery
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I have this condition in my right knee and I'm feeling something is wrong with my left hip replacement.
PatientReceived 2+ prior treatments
Worry about infection staff ect and today don’t wash clean disinfectant the area of skin before and after surgery.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
2019. "Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04075526.
All > Osteoarthritis > Oa
~387 spots leftby Apr 2025
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