CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee - A Vanguard Randomized Controlled Registry Trial (CLEAN Joint Trial)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Royal Victoria Regional Health Centre
RECRUITING
Barrie
Mount Sinai Hospital
NOT_YET_RECRUITING
Toronto
Sunnybrook Holland Centre
RECRUITING
Toronto
Contact Information
Primary
Erin Lillie, MSc
CLEANJoint@sunnybrook.ca
(437) 227-4458
Time Frame
Start Date: 2023-07-25
Estimated Completion Date: 2026-10
Participants
Target number of participants: 400
Treatments
Active_comparator: Chlorhexidine gluconate-alcohol solution
Chlorhexidine gluconate-alcohol solution is a type of solution that has antiseptic properties, which means it helps to eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection.
Active_comparator: Povidone-iodine solution
Povidone-iodine solution is a type of solution that has antiseptic properties, which means it helps to eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov