Infection Prophylaxis in Total Joint Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chlorhexidine Gluconate, Vancomycin Hydrochloride, Povidone-Iodine, Saline.
- Who it may be relevant to
- Registry conditions: Periprosthetic Joint Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)
Overview
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.
Interventions
- Drug Chlorhexidine Gluconate
0.05% chlorhexidine gluconate solution for irrigation - Drug Vancomycin Hydrochloride
2 grams of topical vancomycin hydrochloride added to the wound - Other Povidone-Iodine
0.35% povidone-iodine solution for irrigation - Other Saline
saline for irrigation
Primary outcome measures
- The number of reoperations due to infection [Time frame: Within 1 year of total joint replacement]
Secondary outcome measures (1)
- The number of non-operative surgical site infections requiring antibiotics for treatment. [Time frame: Within 1 year of total joint replacement]
Eligibility criteria
Inclusion criteria
- Patients 18 years of age or older.
- Undergoing primary or aseptic revision TJR.
- No contraindications to study interventions.
- Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.
Exclusion criteria
- Received antibiotics for any reason in the two weeks prior to their TJR.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- Hamilton Health Sciences - Juravinski Hospital and Cancer Centre — Hamilton
Identifiers
NCT: NCT06126614 · PiT-2023