CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Knee Arthroplasty | Revision Total Hip Arthroplasty (RTHA)The goal of this clinical trial is to compare two types of skin preparation solutions (chlorhexidine gluconate-alcohol solution and povidone-iodine solution) that help eliminate harmful bacteria on the skin at the time of surgery for patients having revision arthroplasty surgery of the hip or knee.
The main outcome of interest for the definitive study is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery.
For the pilot trial, our main interest is to determine feasibility of a definitive trial. Feasibility outcomes will include: ability to recruit patients, ability to randomize patients, ability to collect complete data, estimate the event rate of our primary outcome, ability to carry out data linkages and determine the accuracy of collected data.
Participants will be contacted at two time points after surgery to complete a 5-minute survey: after 30 days, and after 1 year.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
1. Aged 18 years or older
2. Scheduled to undergo aseptic revision total hip arthroplasty or total knee arthroplasty with exchange of at least one prosthetic component
Exclusion Criteria:
1. Revision for prosthetic joint infection or wound complication
2. Known history of previous prosthetic joint infection in the operative joint
3. Any degree of clinical concern for prosthetic joint infection
4. History of allergy to iodine, chlorhexidine, or alcohol
Study Location
Mount Sinai Hospital
Mount Sinai HospitalToronto, Ontario
Canada
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Royal Victoria Regional Health Centre
Royal Victoria Regional Health CentreBarrie, Ontario
Canada
Contact Study Team
Sunnybrook Holland Centre
Sunnybrook Holland CentreToronto, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Sunnybrook Health Sciences Centre
- Participants Required
- More Information
- Study ID:
NCT05828810