IO vs IV Vancomycin for Preventing Infection in Shoulder Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare two different antibiotic regimens and techniques during total shoulder arthroplasty.Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are taking medications that affect your immune system, you may not be eligible to participate.
Is vancomycin safe for use in surgeries?
How does the drug vancomycin differ in preventing infections in shoulder surgery?
What data supports the effectiveness of the drug vancomycin in preventing infection in shoulder surgery?
Research suggests that vancomycin, when used as a preventive measure in surgeries like shoulder arthroplasty, can help reduce infections, especially when there is a risk of resistant bacteria. Intraosseous (IO) administration of vancomycin has shown to provide better local antibiotic concentration compared to intravenous (IV) methods in similar surgeries, like total knee arthroplasty, which may imply potential benefits for shoulder surgeries as well.12378
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are having shoulder replacement surgery and can consent to the study. It's not for those with past shoulder surgeries, allergies to certain antibiotics like vancomycin, or conditions that make IO infusion impossible. People with diabetes, weakened immune systems, or a BMI above 35 are also excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Participants receive pre-operative antibiotic regimen including IV antibiotics approximately 1 hour prior to incision
Intra-operative
Participants undergo total shoulder arthroplasty with either IV or IO vancomycin administration; intra-operative sample collection occurs
Post-operative Monitoring
Participants are monitored for adverse reactions and vancomycin levels are measured
Follow-up
Participants are monitored for post-operative complications and infection rates at 30 and 90 days
What Are the Treatments Tested in This Trial?
Interventions
- Vancomycin
Vancomycin is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor