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COMPLETED
NCT05084378
PHASE3

Evaluation of Emerging New Treatments for Infection Prevention in Total Joint Replacement

Sponsor: McMaster University

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

Topical Antibiotic

2 grams Vancomycin powder

DRUG

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