Comparing skin preparation solutions for hip and knee revision surgeries
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)
This study is testing which of two skin cleaning solutions can help reduce the risk of infections in people having hip or knee revision surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 3 sites (Barrie, Ontario and 2 other locations) |
| Trial ID | NCT05828810 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two antiseptic skin preparation solutions, chlorhexidine gluconate-alcohol and povidone-iodine, in reducing the risk of infections during revision total hip and knee arthroplasty surgeries. Participants will be randomly assigned to receive one of the two solutions before their surgery. The primary outcome will be the need for re-operation due to wound complications or infections within one year post-surgery. Additionally, the trial will assess feasibility outcomes such as patient recruitment and data collection methods. Follow-up surveys will be conducted at 30 days and one year after surgery to gather relevant data.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older scheduled for aseptic revision total hip or knee arthroplasty involving the exchange of at least one prosthetic component.
Not a fit: Patients undergoing revision surgery for prosthetic joint infection or with a history of allergy to the study solutions may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could help identify the most effective skin preparation solution, potentially reducing the risk of infections and the need for additional surgeries.
How similar studies have performed: Previous studies have explored antiseptic solutions in surgical settings, but this specific comparison in revision arthroplasty is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barrie, Ontario and 2 other locations
- Royal Victoria Regional Health Centre — Barrie, Ontario, Canada (Active_not_recruiting)
- Health Sciences North — Greater Sudbury, Ontario, Canada (Recruiting)
- Sunnybrook Holland Centre — Toronto, Ontario, Canada (Active_not_recruiting)
Study contacts
- Principal investigator: Raman Mundi, MD MSc FRCSC — Sunnybrook Health Sciences Centre
- Study coordinator: Erin Lillie, MSc
- Email: CLEANJoint@sunnybrook.ca
- Phone: (437) 227-4458
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.