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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients 18 years of age or older.

• Undergoing primary or aseptic revision TJR.

• No contraindications to study interventions.

• Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.

Locations
Other Locations
Canada
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
RECRUITING
Hamilton
Contact Information
Primary
Lindsay Maharaj, MSc
maharajli@hhsc.ca
905-521-2100
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2028-11
Participants
Target number of participants: 21006
Treatments
Experimental: Povidone-Iodine 0.35% Lavage Solution
The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction.~The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
Experimental: Povidone-Iodine 0.35% Lavage Solution and Vancomycin
The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.~The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
Experimental: Chlorhexidine Gluconate 0.05% Lavage Solution
The study lavage solution (chlorhexidine-gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction.~The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
Experimental: Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin
The study lavage solution (chlorhexidine gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.~The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
Active_comparator: Saline Lavage Solution
The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction.~The study lavage solution will be a total volume of 1 litre.
Experimental: Saline Lavage Solution and Vancomycin
The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction.~Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.
Related Therapeutic Areas
Sponsors
Leads: Hamilton Health Sciences Corporation
Collaborators: Ontario Clinical Oncology Group (OCOG), McMaster University

This content was sourced from clinicaltrials.gov