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Evaluation of Emerging New Treatments for Infection Prevention in Total Joint Replacement
Sponsor: McMaster University
Summary
At the end of total joint replacement (TJR) surgery, surgeons wash and clean the surgical wound. This is done to lower the risk of infections. Currently, most surgeons use saline to wash the surgical wound and do not place antibiotics in the wound . However, some recent studies have shown that using povidone-iodine and chlorhexidine-based solutions (both are types of antiseptics) to wash the surgical site and placing antibiotics directly into the wound may be effective in reducing infections in TJR surgery compared to saline and no antibiotics. However, no study has determined which solution is better at reducing the number of infections in patients undergoing TJR. The investigators also do not know if the addition of antibiotics applied to the wound will decrease infections. Currently, there are no surgical guidelines around infection prevention in total joint replacement. A large scale, multi-site, pragmatic 3 x 2 factorial randomized controlled trial is need that compares these six treatment groups. However, before this, a smaller pilot study must be conducted to determine the feasibility of a larger study. PREVENT-iT will address these important gaps in knowledge and clinical practice.
Official title: Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement: A Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
495
Start Date
2022-03-11
Completion Date
2024-10-28
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Povidone-Iodine Lavage Solution
0.35% povidone-iodine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.35% povidone-iodine and sterile isotonic saline solution may also be used.
Chlorhexidine Lavage Solution
0.05% chlorhexidine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.05% chlorhexidine and sterile isotonic saline may also be used.
Topical Antibiotic
2 grams Vancomycin powder
Saline Lavage Solution
1 litre of sterile isotonic saline
Locations (6)
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Hamilton Health Sciences- Juravinkski Hospital
Hamilton, Ontario, Canada
Montreal General Hospital
Montreal, Quebec, Canada
St. Mary's Hospital
Montreal, Quebec, Canada
Hospital Clinic Barcelona
Barcelona, Spain
Vall d'Hebron University Hospital
Barcelona, Spain