Evaluation of Emerging New Treatments for Infection Prevention in Total Joint Replacement (PREVENT-IT)

NCT05084378 PHASE3 COMPLETED

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.

Details

Lead sponsor	Hamilton Health Sciences Corporation
Phase	PHASE3
Status	COMPLETED
Enrolment	495
Start date	Fri Mar 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Periprosthetic Joint Infection
• Draining Wound

Interventions

• Povidone-Iodine Lavage Solution
• Chlorhexidine Lavage Solution
• Topical Antibiotic
• Saline Lavage Solution

Countries

Canada, Spain