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

PiT-2023

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.

2024-05-01

2028-11-01

2028-11-01

Recruiting

Early phase I

21006

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 21006, 'type': 'ESTIMATED'}}

2024-06-03