Actively Recruiting
Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prevention in Total Joint Replacement (PREVENT-iT)
Led by Hamilton Health Sciences Corporation · Updated on 2026-05-22
21006
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hamilton Health Sciences Corporation
Lead Sponsor
M
McMaster University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Osteoarthritis (OA) is a common cause of disability worldwide, affecting over 500 million people. Total joint replacements (TJR) are often used when other treatments fail, but infection is the main cause of joint replacement failure, leading to more complex repeat surgeries. This clinical trial aims to evaluate whether using antiseptic washes and placing antibiotics directly into the surgical wound can reduce infections requiring reoperation after hip or knee replacements. Participants undergoing primary or aseptic revision total joint replacements will be randomly assigned to one of six groups. These groups receive different combinations of antiseptic lavage solutions—povidone-iodine, chlorhexidine gluconate, or saline—and may also receive topical vancomycin antibiotic applied directly to the joint wound before closure. The antiseptic solution is poured into the surgical site and left for 3 minutes before removal. The study compares infection rates across these treatment combinations. During the year following surgery, participants will be monitored for infections that require reoperation or antibiotic treatment. Researchers will track the number of infections in each group to assess if the treatments reduce infection risk. The study includes regular follow-ups and evaluations of surgical site infections to determine outcomes and ensure participant safety over the 12-month period after joint replacement surgery.
CONDITIONS
Brief Title
Infection Prophylaxis in Total Joint Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Undergoing primary or aseptic revision total joint replacement
- No contraindications to study interventions
- Informed consent obtained and willingness to follow the study protocol
You will not qualify if you...
- Received antibiotics for any reason in the two weeks before surgery
- Chronic or acute infection at or near the joint replacement site
- Prior history of periprosthetic joint infection or reoperation due to infection
- Surgery due to a fracture diagnosis
- Open infected wounds on the affected limb
- Undergoing bilateral total joint replacement
- Currently enrolled in a study that prohibits co-enrollment
- Previous enrollment in this trial or pilot study
- Any condition that interferes with assessments or completion of the trial as judged by the Investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of surgery
Participants undergo total joint replacement surgery where one of several study lavage solutions is used during surgery. The lavage solution is poured into the joint, left for 3 minutes, then removed by suction. For some participants, vancomycin is also applied to the deep joint immediately prior to closure.
1 surgical visit (in-person)
Duration - Up to 1 year after total joint replacement
Participants are monitored for signs of infection and recovery after surgery, including tracking any reoperations or infections requiring antibiotics.
Follow-up visits as scheduled by treating team
Trial Site Locations
Total: 1 location
1
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3
Actively Recruiting
Research Team
L
Lindsay Maharaj, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
6
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