Clinical trial NCT04075526: Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
Official title: Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 2129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. The potential benefits of these interventions are significant both from the perspective of reducing morbidity and mortality for the patient, and from a cost-effectiveness and value-based perspective. To this end, our study seeks to assess the direct and indirect costs associated with the treatment and control groups. We anticipate that the administration of a VPIP protocol will both reduce the incidence of PJI in high risk groups relative to the control arm and will demonstrate added value from a cost-effectiveness perspective.

This study looks to examine off-label use of Vancomycin Powder and Povidone Iodine 10% solution. Both products are lawfully marketed in the United States. This study is not intended to be reported to the FDA as a well-controlled study in support of a new indication and there is no intent to use it to support any other significant change in the labeling or advertising of either drug.

This study does not involve a route of administration, dose, patient population, or other factor that significantly increased the risk (or decreases the acceptability of the risk) associated with the use of the drug product. The routes and dosages being tested in this protocol are part of standard clinical care in most total joint arthroplasty surgeries.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Rate of periprosthetic infection (PJI) after elective total joint arthroplasty.
timeFrame: 90 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Health
state: California
city: Denver
country: United States
facility: Centura Health
state: Colorado
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Sparta
country: United States
facility: The Orthopedic Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: New York University Dept of Orthopedic Surgery
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Ohio
state: Ohio
Study officials:
affiliation: NYU Langone
name: Ran Schwarzkopf, MD
role: PRINCIPAL_INVESTIGATOR
References: