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

Recruiting in Palo Alto (17 mi)

+13 other locations

Ran Schwarzkopf, MD | NYU Langone Health

Overseen byRan Schwarzkopf, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ran Schwarzkopf, MD

Principal Investigator

NYU Langone

Eligibility Criteria

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.

Inclusion Criteria

Patient understand the risks and benefits associated with TJA and willing to cooperate and follow study protocol and visit schedule

I do not have an infection in the leg or joint that will be operated on.

I have no open wounds on my leg that needs surgery.

See 2 more

Exclusion Criteria

I don't have any planned procedures within 3 months after surgery.

I am able to understand and follow the study's requirements.

I have an active infection in my leg or joint where surgery is planned.

See 7 more

Treatment Details

Interventions

Conventional (Procedure)
Povidone iodine (Antiseptic)
Vancomycin powder (Antibiotic)

Trial OverviewThe 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.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Povidone iodine and vancomycin powderExperimental Treatment2 Interventions

Group II: Povidone iodine aloneExperimental Treatment1 Intervention

Group III: ConventionalActive Control1 Intervention

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

Group IV: Vancomycin powder aloneActive Control1 Intervention