Antibiotics in Joint Replacement for Preventing Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare infection rates when patients, elected for primary or aseptic revision THA / TKA, have a single intravenous antibiotic dose versus one single intravenous antibiotic dose in combination with intra-articular antibiotics. This is a prospective, randomized clinical survey on selected outcome measurements on 1834 subjects who will be recruited in a period of about 2 years.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is vancomycin powder safe for use in joint replacement surgeries?
How is the drug Intra-articular Vancomycin Powder different from other treatments for preventing infections in joint replacement?
Intra-articular Vancomycin Powder is unique because it is applied directly into the surgical wound during joint replacement, which may help reduce the risk of infection more effectively than standard systemic antibiotics alone. This direct application targets the area most at risk for infection, potentially offering a more focused approach to preventing infections in joint replacements.12456
What data supports the effectiveness of the drug Intra-articular Vancomycin Powder in preventing infections in joint replacement surgeries?
Who Is on the Research Team?
Benoit Benoit, MD
Principal Investigator
CIUSSS du Nord de l'Île de Montreal
Are You a Good Fit for This Trial?
Adults over 18 needing a new hip or knee joint (arthroplasty) due to osteoarthritis, bone death, arthritis, or previous joint replacement issues can join. They must be in good health for surgery and able to follow up for 2 years. People with skin diseases, infections, vancomycin allergies, or enrolled in other trials cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of IV cefazolin and, for some, an additional intra-articular vancomycin powder during knee or hip arthroplasty
Follow-up
Participants are monitored for infection rates and other outcomes after surgery
Long-term Follow-up
Participants are monitored for long-term infection rates and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Intra-articular Vancomycin Powder
Intra-articular Vancomycin Powder is already approved in United States, European Union, Canada, Japan for the following indications:
- Severe bacterial infections
- MRSA infections
- Clostridium difficile-associated diarrhea and enterocolitis
- Severe bacterial infections
- MRSA infections
- Endocarditis
- Peritonitis
- Severe bacterial infections
- MRSA infections
- Clostridium difficile-associated diarrhea and enterocolitis
- Severe bacterial infections
- MRSA infections
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead Sponsor