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CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee

Study acronym: CLEANJoint
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 3 of 3 sites
  2. Site details revised at 1 of 3 sitesv5
  3. Primary completion date: Jul 2025 to Nov 2026
    • Study completion date: Oct 2026 to Nov 2026
    • Study sites revised (3)
    v4
  4. Phase: Phase 4 to Not applicablev3 Show 8 more changesShow less
    • Enrollment target: 120 to 400
    • Primary completion date: Jul 2024 to Jul 2025
    • Start date: May 18, 2023 to Jul 25, 2023
    • Primary endpoints revised (6)
    • Study sites: 1 to 3
    • Study completion date: Oct 2025 to Oct 2026
    • Interventions: surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution (Drug) to Chlorhexidne Gluconate-Alcohol Skin Preparation (Procedure), Poviodine-iodine Skin Preparation (Procedure)
    • Study description shortened, about 257 words
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 2025 to Jul 2024
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2023 to May 18, 2023
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05828810
Lead Sponsor Sunnybrook Health Sciences Centre
Conditions
(from sponsor)		 Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov