NCT06126614

Infection Prophylaxis in Total Joint Replacement

Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21,006 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis (OA) is the most common cause of disability in older adults worldwide affecting 7% of the global population, or more than 500 million people globally. Total joint replacements (TJR) can help bring relief to those with osteoarthritis when other treatment options are no longer helpful. Infection is the main reason hip and knee replacements "fail". Failure leads to repeat surgeries that are often more complicated and less likely to be successful than the first surgery. Reducing the risk of infection is extremely important, antiseptic washes and antibiotics may help us do that. After joint replacement surgery, orthopaedic surgeons wash and clean the surgical wound to lower the risk of infection. The goal of this clinical trial is to determine if the use of antiseptic solutions to wash the surgical site and placing an antibiotic directly into the wound will reduce the number of infections requiring reoperation. Patients having total joint replacements will be randomized (like flipping a coin) to receive 6 possible combinations of washes and / or antibiotics. Participants will be followed for one year after TJR to compare the rate of infection in each group.

Conditions

• Periprosthetic Joint Infection

Interventions

Type	Name	Description
DRUG	Chlorhexidine Gluconate	0.05% chlorhexidine gluconate solution for irrigation
DRUG	Vancomycin Hydrochloride	2 grams of topical vancomycin hydrochloride added to the wound
OTHER	Povidone-Iodine	0.35% povidone-iodine solution for irrigation
OTHER	Saline	saline for irrigation

Timeline

• Start date: 2024-05-07
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2023-11-13
• Last updated: 2024-09-19

Locations

1 site across 1 country: Canada