Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty

Sponsor

NYU Langone Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT04075526

Collaborator

(none)

10,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

714.3

Patients Per Site

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Povidone iodine Drug: Vancomycin powder Other: Conventional	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Povidone iodine and vancomycin powder	Drug: Povidone iodine To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure. Drug: Vancomycin powder 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
Experimental: Povidone iodine alone	Drug: Povidone iodine To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
Active Comparator: Vancomycin powder alone	Drug: Vancomycin powder 2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
Active Comparator: Conventional neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation	Other: Conventional No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort

Outcome Measures

Primary Outcome Measures

Rate of periprosthetic infection (PJI) after elective total joint arthroplasty. [90 Days]
The definition of periprosthetic infection exists when the following criteria are met: NEW MSIS criteria for PJI: 1 major criteria (2) or 6 minor criteria (6) 26-28 Major Criteria: [1] sinus tract [2] + Cx from 2 separate aspirations Minor Criteria: [1] ESR >30 mm/hr (1 point), [2] D-dimer >860 ng/mL or CRP >1 mg/dL [2] increased synovial WBC (>3000 cells/microliter) [4] alpha-defensin (signal-to-cutoff ratio>1) [5] leukocyte esterase (++) [6] increased synovial PMNs of >80% [7] synovial CRP >6.9 mg/L

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
6	Boston Medical Center	Boston	Massachusetts	United States	02118
7	New England Baptist Hospital	Boston	Massachusetts	United States	02120
8	The Orthopedic Institute of New Jersey	Sparta	New Jersey	United States	07871
9	New York University Dept of Orthopedic Surgery	New York	New York	United States	10003
10	Hospital for Special Surgery	New York	New York	United States	10021
11	Mount Sinai Hospital	New York	New York	United States	10029
12	Columbia	New York	New York	United States	10036
13	St. Francis Hospital	Roslyn	New York	United States	11576
14	Cleveland Clinic Ohio	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Ran Schwarzkopf, MD, NYU Langone

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT04075526

Other Study ID Numbers:

19-00851

First Posted:

Aug 30, 2019

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022