RecruitingNot ApplicableNCT05828810

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

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)

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

400 participants

Start Date

Jul 25, 2023

Study Type

INTERVENTIONAL

Conditions

Revision Total Hip Arthroplasty (RTHA)Revision Total Knee Arthroplasty

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two antiseptic skin preparation solutions for their ability to reduce infection risk in patients undergoing revision total hip or knee arthroplasty (repeat joint replacement surgery). Periprosthetic joint infection is one of the most feared and costly complications after joint replacement — it can require multiple surgeries, prolonged antibiotic treatment, and sometimes permanent removal of the implant. Proper skin antisepsis before surgery is a key infection prevention measure, but it is unclear which preparation solution is most effective for revision procedures. Adults aged 18 and older who are scheduled for revision of a hip or knee replacement for non-infectious reasons (i.e., mechanical failure, loosening) and who do not have a history of iodine, chlorhexidine, or alcohol allergies are eligible. Patients having revision surgery for an established prosthetic joint infection, or with any clinical concern for infection, are not eligible, as they represent a different clinical scenario. Participants will be assigned to receive one of the antiseptic preparations, and rates of surgical site infection will be tracked. This research is practically important because revision joint replacement is substantially more complex and higher risk than primary replacement, and even modest improvements in infection prevention could spare patients the enormous physical and emotional toll of a post-surgical infection. The findings will help standardize evidence-based skin preparation protocols for this growing patient population.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREChlorhexidne Gluconate-Alcohol Skin Preparation

Participants will undergo skin antisepsis with 4% chlorhexidine gluconate pre-wash, followed by 2% chlorhexidine gluconate with 70% isopropyl alcohol skin preparation. The surgical field to be sterilized will be at the discretion of the surgical team, but typically includes the distal torso to ankle for patients undergoing hip arthroplasty and proximal thigh to ankle for patients undergoing knee arthroplasty. Pre-wash of the surgical area will be carried out using a wet chlorhexidine surgical scrub brush followed by immediate drying using towels. The definitive preparation will then be carried out using tinted chlorhexidine gluconate-alcohol sponges applied with forceps. The drying time and the minimum number of sponge packs used will comply with the product 'Instructions for Use'. The drapes can be applied as per the surgeon's usual approach and they will be treated according to the institution and surgeon's routine practice for draping and surgical site infection prevention.

PROCEDUREPoviodine-iodine Skin Preparation

Participants will undergo skin antisepsis with 7.5% povidone-iodine detergent pre-wash, followed by 10% povidone-iodine skin preparation. The surgical field to be sterilized will be at the discretion of the surgical team, but typically includes the distal torso to ankle for patients undergoing hip arthroplasty and proximal thigh to ankle for patients undergoing knee arthroplasty. Pre-wash of the surgical area will be carried out using iodine detergent soaked gauze pads followed by immediate drying using towels. The definitive preparation will then be carried out using povidone-iodine soaked gauze pads applied with forceps. The drapes can be applied as per the surgical team's usual approach and they otherwise will be treated according to the institution and surgeon's routine practice for draping and surgical site infection prevention.

Locations(3)

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Sunnybrook Holland Centre

Toronto, Ontario, Canada

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NCT05828810

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