Dilute Betadine Lavage in the Prevention of Postoperative Infection

August 16, 2021 updated by: Rush University Medical Center

Efficacy of a Dilute Betadine Lavage in the Prevention of Postoperative Infection in Revision Total Knee Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

505

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Betadine Lavage
dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation
Procedure: Betadine Lavage
Following revision knee surgery, a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000 ml of sterile saline irrigation
Other Names:
  • Betadine
  • Lavage
  • Infection
  • Revision
  • Knee
  • Arthroplasty
Placebo Comparator: Saline Lavage
2000 ml sterile saline lavage alone
Procedure: Saline Lavage
Following revision knee surgery, 2000ml sterile saline lavage prior to closure
Other Names:
  • Saline
  • Lavage
  • Infection
  • Revision
  • Knee
  • Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infection Rate
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

Central DuPage Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

July 8, 2019

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10031106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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