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Prospective Randomized Evaluation of Emerging Novel Treatments for Infection prophylaxis in Total Joint Replacement (PREVENT-iT)
EU CTIS ID: 2024-515055-38-00
What this study is testing
To determine in patients undergoing primary or aseptic revision TJR if: 1. A 0.35% PI irrigation solution compared to a normal saline irrigation solution reduces the risk of reoperation due to infection within 12 months of primary or aseptic revision hip or knee TJR. 2. A 0.05% chlorhexidine irrigation solution compared to a normal saline irrigation solution reduces the risk of reoperation due to infection within 12 months of primary or aseptic revision hip or knee TJR. 3. The use of local vancomycin versus no local vancomycin reduces the risk of reoperation due to infection within 12 months of primary or aseptic revision hip or knee TJR.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients 18 years of age or older.
- Undergoing primary or aseptic revision TJR
You likely can't join if
- Received antibiotics for any reason in the two weeks prior to their TJR.
- Prior enrollment in the trial including the pilot study.
- Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.
- A contraindication to study interventions.
- Chronic or acute infection at or near the TJR site.
- Prior history of periprosthetic joint infection including any reoperation due to infection.
See the full eligibility criteria
- Patients 18 years of age or older.
- Undergoing primary or aseptic revision TJR
- Received antibiotics for any reason in the two weeks prior to their TJR.
- Prior enrollment in the trial including the pilot study.
- Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.
- A contraindication to study interventions.
- Chronic or acute infection at or near the TJR site.
- Prior history of periprosthetic joint infection including any reoperation due to infection.
- Undergoing surgery for a diagnosis of a fracture.
- Open infected wounds on affected limb
- Undergoing bilateral TJR.
- Currently enrolled in a study that does not permit co-enrollment
- Did not provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.