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Dilute Betadine Lavage in the Prevention of Postoperative Infection

Primary Purpose

Prosthesis-Related Infections, Arthroplasty

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Betadine Lavage
Saline Lavage
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prosthesis-Related Infections focused on measuring Revision, Knee, Arthroplasty, Betadine, Lavage, Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled to undergo revision total knee arthroplasty

Exclusion Criteria:

  • Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
  • Age ≤ 17.
  • Allergy to povidone iodine.
  • Any condition requiring antibiotics 14 days prior to arriving for surgery.
  • Patients with chronic immunosuppression (such as HIV/AIDS).
  • Unable to adhere to follow up schedule and treatment.
  • Patients scheduled to undergo revision total knee arthroplasty for infectious reasons.

Sites / Locations

  • Rush University Medical Center
  • Central DuPage Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Betadine Lavage

Saline Lavage

Arm Description

dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation

2000 ml sterile saline lavage alone

Outcomes

Primary Outcome Measures

Infection Rate

Secondary Outcome Measures

Full Information

First Posted
August 2, 2010
Last Updated
August 16, 2021
Sponsor
Rush University Medical Center
Collaborators
Central DuPage Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01175044
Brief Title
Dilute Betadine Lavage in the Prevention of Postoperative Infection
Official Title
Efficacy of a Dilute Betadine Lavage in the Prevention of Postoperative Infection in Revision Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
July 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Central DuPage Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the efficacy of a dilute betadine solution in reducing infectious complications in revision total knee arthroplasty. The investigators will enroll patients who are scheduled to undergo a revision total knee arthroplasty. Patients will be randomized into two groups. The treatment group will receive a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation and the control group will receive the 2000ml sterile saline lavage alone.
Detailed Description
Infections in total knee arthroplasty are still a major source of morbidity and mortality in Orthopaedics. They often necessitate long term antibiotics, reoperation, and can lead to further complications such as sepsis or even death. Infection prevention remains one of the primary goals of an orthopedic surgeon. While most sources report the infection rate for primary total knee arthroplasty to be less than 1%, the reported rate for infection in revision total knee arthroplasties has been reported to be as high as 5.6%. Despite steps taken towards infection prevention such as proper administration of preoperative antibiotics, strict adherence to sterile methods, and meticulous sterile preparation of the surgical site; infection remains higher in the total knee revision arthroplasty patient population when compared to primary total knee arthroplasty. A dilute betadine lavage (0.35% to 1% povidone iodine) prior to surgical closure has been shown in general surgical procedures as well as orthopaedic spine surgeries to reduce the infection rate in their patients, but this has not been examined in total joint arthroplasty. The study will enroll patients who are scheduled to undergo a revision total knee arthroplasty. Patients will be randomized into two groups. The treatment group will receive a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation and the control group will receive the 2000ml sterile saline lavage alone. All other treatment will be standard of care. Subjects will then be followed for one year post surgery for infection, as defined by Appendix 1, at intervals of 2 weeks, 6 weeks, 3 months, and one year from the date of surgery. During these visits patients will receive standard post operative care which includes infection screening. If an infection is clinically suspected with symptoms such as warmth and erythema over the joint, reduced mobility of the joint, and increasing pain at the joint, then infection data will be collected which will consist of a Erythrocyte Sedimentation Rate, C-Reactive Protein levels and a synovial fluid sample will be taken for white blood cell count and bacterial culture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis-Related Infections, Arthroplasty
Keywords
Revision, Knee, Arthroplasty, Betadine, Lavage, Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
505 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Betadine Lavage
Arm Type
Active Comparator
Arm Description
dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation
Arm Title
Saline Lavage
Arm Type
Placebo Comparator
Arm Description
2000 ml sterile saline lavage alone
Intervention Type
Procedure
Intervention Name(s)
Betadine Lavage
Other Intervention Name(s)
Betadine, Lavage, Infection, Revision, Knee, Arthroplasty
Intervention Description
Following revision knee surgery, a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000 ml of sterile saline irrigation
Intervention Type
Procedure
Intervention Name(s)
Saline Lavage
Other Intervention Name(s)
Saline, Lavage, Infection, Revision, Knee, Arthroplasty
Intervention Description
Following revision knee surgery, 2000ml sterile saline lavage prior to closure
Primary Outcome Measure Information:
Title
Infection Rate
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled to undergo revision total knee arthroplasty Exclusion Criteria: Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance). Age ≤ 17. Allergy to povidone iodine. Any condition requiring antibiotics 14 days prior to arriving for surgery. Patients with chronic immunosuppression (such as HIV/AIDS). Unable to adhere to follow up schedule and treatment. Patients scheduled to undergo revision total knee arthroplasty for infectious reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig J Della Valle, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States

12. IPD Sharing Statement

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Dilute Betadine Lavage in the Prevention of Postoperative Infection

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