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Infection Prophylaxis in Total Joint Replacement

Study acronym: PREVENT-iT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor 2 versions Re-verified since Sep 6, 2024, no change to tracked fieldsv5-v6
  2. Minor Start date changed from estimate of May 2024 to May 7, 2024v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2023 to May 2024
    • Study sites: 0 to 1
    v3
  4. Notable Primary endpoint revised
    • Secondary endpoint revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06126614
Lead Sponsor Hamilton Health Sciences Corporation
Collaborators: McMaster University, Ontario Clinical Oncology Group (OCOG)
Conditions
(from sponsor)
Periprosthetic Joint Infection
Enrollment 21,006 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov