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RECRUITING
NCT06126614
PHASE3

Infection Prophylaxis in Total Joint Replacement

Sponsor: Hamilton Health Sciences Corporation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21006

Start Date

2024-05-07

Completion Date

2028-11

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

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

Locations (1)

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada