CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Recruiting now · Not applicable
Conditions studied: Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
In brief
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.
Key facts
- Study ID
- NCT05828810
- Run by
- Sunnybrook Health Sciences Centre
- People needed
- 400
- Starts
- 2023-07-25
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged 18 years or older
- Scheduled to undergo aseptic revision total hip arthroplasty or total knee arthroplasty with exchange of at least one prosthetic component
You may not qualify if…
- Revision for prosthetic joint infection or wound complication
- Known history of previous prosthetic joint infection in the operative joint
- Any degree of clinical concern for prosthetic joint infection
- History of allergy to iodine, chlorhexidine, or alcohol
Where it is running
- Health Sciences North — Greater Sudbury, Ontario, Canada (enrolling)
- Royal Victoria Regional Health Centre — Barrie, Ontario, Canada
- Sunnybrook Holland Centre — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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