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

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

July 25, 2023

Primary Completion Date

July 31, 2025

Study Completion Date

October 31, 2026

Conditions
Revision Total Hip Arthroplasty (RTHA)Revision Total Knee Arthroplasty
Interventions
PROCEDURE

Chlorhexidne 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."

PROCEDURE

Poviodine-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."

Trial Locations (3)

L4M 6M2

RECRUITING

Royal Victoria Regional Health Centre, Barrie

M4Y 1H1

RECRUITING

Sunnybrook Holland Centre, Toronto

M5G 1X5

NOT_YET_RECRUITING

Mount Sinai Hospital, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER