Dilute Betadine Lavage in the Prevention of Postoperative Infection
Information source: Rush University Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prosthesis-Related Infections; Arthroplasty
Intervention: Betadine Lavage (Procedure); Saline Lavage (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Rush University Medical Center Official(s) and/or principal investigator(s): Craig J Della Valle, MD, Principal Investigator, Affiliation: Rush University Medical Center
Overall contact: Darren R Plummer, BBA, MBA, Phone: 312-432-2468, Email: darren.plummer@rushortho.com
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.
Clinical Details
Official title: Efficacy of a Dilute Betadine Lavage in the Prevention of Postoperative Infection in Revision Total Knee Arthroplasty
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Infection Rate
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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.
Locations and Contacts
Darren R Plummer, BBA, MBA, Phone: 312-432-2468, Email: darren.plummer@rushortho.com
Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting Craig J Della Valle, MD, Principal Investigator Darren R Plummer, BBA, MBA, Sub-Investigator
Central DuPage Hospital, Winfield, Illinois 60190, United States; Recruiting Scott Sporer, MD, Principal Investigator
Additional Information
Starting date: August 2010
Last updated: August 29, 2014
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