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

Primary Purpose

Osteoarthritis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Povidone iodine
Vancomycin powder
Conventional
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eisenhower Health
  • Centura HealthRecruiting
  • Cleveland Clinic FloridaRecruiting
  • Rush University Medical CenterRecruiting
  • Brigham and Women's HospitalRecruiting
  • Boston Medical Center
  • New England Baptist HospitalRecruiting
  • The Orthopedic Institute of New JerseyRecruiting
  • New York University Dept of Orthopedic SurgeryRecruiting
  • Hospital for Special Surgery
  • Mount Sinai Hospital
  • ColumbiaRecruiting
  • St. Francis HospitalRecruiting
  • Cleveland Clinic OhioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Povidone iodine and vancomycin powder

Povidone iodine alone

Vancomycin powder alone

Conventional

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of periprosthetic infection (PJI) after elective total joint arthroplasty.
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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2019
Last Updated
December 30, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04075526
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Povidone iodine and vancomycin powder
Arm Type
Experimental
Arm Title
Povidone iodine alone
Arm Type
Experimental
Arm Title
Vancomycin powder alone
Arm Type
Active Comparator
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
neither povidone iodine, vancomycin powder, nor polymyxin/bacitracin irrigation
Intervention Type
Drug
Intervention Name(s)
Povidone iodine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vancomycin powder
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of periprosthetic infection (PJI) after elective total joint arthroplasty.
Description
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
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Waren
Phone
212-598-6245
Email
Daniel.Waren@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Schwarzkopf, MD
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eisenhower Health
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Schnaser, MD
Phone
909-558-4729
First Name & Middle Initial & Last Name & Degree
Erik Schnaser, MD
Facility Name
Centura Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Dennis, MD
Email
douglasdennis@centura.org
First Name & Middle Initial & Last Name & Degree
Douglas Dennis, MD
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Higuera, MD
Phone
954-659-5000
Email
higuerc@ccf.org
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Levine, MD
Phone
877-632-6637
Email
levine.research@rushortho.com
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonia Chen
Phone
617-732-5500
Email
afchen@bwh.harvard.edu
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kain, MD
Phone
781-744-5100
Facility Name
New England Baptist Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Smith, MD
Phone
617-754-5000
Facility Name
The Orthopedic Institute of New Jersey
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
07871
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Dundon, MD
Email
jmdundon14@gmail.com
First Name & Middle Initial & Last Name & Degree
John Dundon, MD
Facility Name
New York University Dept of Orthopedic Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Schwarzkopf, MD
Email
Ran.Schwarzkopf@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Ran Schwarzkopf, MD
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Vigdorchik
Phone
212-606-1992
Email
VigdorchikJ@hss.edu
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bill Hamilton, MD
Phone
212-241-6500
Facility Name
Columbia
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Cooper, MD
Phone
212-305-4565
Email
hjc2008@cumc.columbia.edu
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Long
Email
doctor_long@hotmail.com
Facility Name
Cleveland Clinic Ohio
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Piuzzi, MD
Phone
216-444-2200
Email
piuzzin@ccf.org

12. IPD Sharing Statement

Learn more about this trial

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

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