Dilute Betadine Lavage in the Prevention of Postoperative Infection
Efficacy of a Dilute Betadine Lavage in the Prevention of Postoperative Infection in Revision Total Knee Arthroplasty
1 other identifier
interventional
505
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2010
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 2, 2010
CompletedFirst Posted
Study publicly available on registry
August 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2019
CompletedAugust 17, 2021
August 1, 2021
8.4 years
August 2, 2010
August 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infection Rate
12 months
Study Arms (2)
Betadine Lavage
ACTIVE COMPARATORdilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation
Saline Lavage
PLACEBO COMPARATOR2000 ml sterile saline lavage alone
Interventions
Following revision knee surgery, a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000 ml of sterile saline irrigation
Following revision knee surgery, 2000ml sterile saline lavage prior to closure
Eligibility Criteria
You may qualify if:
- Scheduled to undergo revision total knee arthroplasty
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- Central DuPage Hospitalcollaborator
Study Sites (2)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig J Della Valle, MD
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2010
First Posted
August 4, 2010
Study Start
August 1, 2010
Primary Completion
January 1, 2019
Study Completion
July 8, 2019
Last Updated
August 17, 2021
Record last verified: 2021-08