IO vs IV Vancomycin for Preventing Infection in Knee Surgery
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive medications, you may not be eligible to participate.
What data supports the effectiveness of the drug Vancomycin in preventing infection in knee surgery?
Research shows that using vancomycin directly in the bone (intraosseous) during knee surgery can lead to higher local antibiotic levels compared to traditional IV methods, potentially reducing infection rates. Additionally, intraosseous vancomycin has been associated with lower rates of joint infections after knee surgery without increasing complications.12345
Is intraosseous vancomycin safe for use in knee surgery?
How is the drug vancomycin used differently in this knee surgery trial?
What is the purpose of this trial?
This trial is comparing two methods of giving an antibiotic during knee replacement surgery: through a vein and directly into the bone. It aims to see which method helps the antibiotic reach the knee area better and if it affects infection rates after surgery. Delivering antibiotics directly into the bone achieves higher local concentrations with fewer side effects and has been shown to be more effective for preventing infection following surgery.
Eligibility Criteria
This trial is for adults over 18 who are having their first knee replacement surgery without a tourniquet. They must understand the study and agree to participate. It's not for people with weak immune systems, uncontrolled diabetes (Hemoglobin A1C >7.5), allergies to vancomycin or similar antibiotics, BMI over 35, or those who've had previous knee surgeries.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo total knee arthroplasty with either intraosseous or intravenous vancomycin administration
Follow-up
Participants are monitored for safety and effectiveness after treatment, including 30-day and 90-day post-operative complication rates
Treatment Details
Interventions
- Vancomycin
Vancomycin is already approved in United States, European Union, Canada, Japan for the following indications:
- Severe infections caused by susceptible strains of methicillin-resistant staphylococci
- Enterocolitis caused by Staphylococcus aureus
- Staphylococcal endocarditis
- Severe infections caused by Gram-positive bacteria
- Endocarditis
- Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD)
- Severe infections caused by susceptible strains of methicillin-resistant staphylococci
- Enterocolitis caused by Staphylococcus aureus
- Severe infections caused by Gram-positive bacteria
- Endocarditis
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor