Clinical trial NCT06126614: Infection Prophylaxis in Total Joint Replacement
Official title: Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Periprosthetic Joint Infection
Keywords: Arthroplasty
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Ontario Clinical Oncology Group (OCOG)
First posted: 2023-11-13
Enrollment: 21006
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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 criteria: Inclusion Criteria:

1. Patients 18 years of age or older.
2. Undergoing primary or aseptic revision TJR.
3. No contraindications to study interventions.
4. Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.

Exclusion Criteria:

1. Received antibiotics for any reason in the two weeks prior to their TJR.
2. Chronic or acute infection at or near the TJR site.
3. Prior history of periprosthetic joint infection including any reoperation due to infection.
4. Undergoing surgery for a diagnosis of a fracture.
5. Open infected wounds on affected limb.
6. Undergoing bilateral TJR.
7. Currently enrolled in a study that does not permit co-enrollment.
8. Prior enrollment in the trial including the pilot study
9. Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.

Primary outcomes:
measure: The number of reoperations due to infection
timeFrame: Within 1 year of total joint replacement
Secondary outcomes:
measure: The number of non-operative surgical site infections requiring antibiotics for treatment.
timeFrame: Within 1 year of total joint replacement
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences / McMaster University
name: Thomas J Wood, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: