Status:
ACTIVE_NOT_RECRUITING
Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
Lead Sponsor:
NYU Langone Health
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
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.
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
2129 Patients enrolled
Trial Details
Trial ID
NCT04075526
Start Date
October 1 2019
End Date
January 1 2026
Last Update
December 3 2025
Active Locations (14)
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1
Eisenhower Health
Rancho Mirage, California, United States, 92270
2
Centura Health
Denver, Colorado, United States, 80210
3
Cleveland Clinic Florida
Weston, Florida, United States, 33331
4
Rush University Medical Center
Chicago, Illinois, United States, 60612