At a glance
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Intraosseous vs. Intravenous Vancomycin Administration in Total Shoulder Arthroplasty: Changing the Paradigm
In Brief
A Phase 4 clinical trial evaluating Intervention - Intraosseous (IO) administration of vancomycin and Control - Standard IV administration of vancomycin for Shoulder Injuries. Active but no longer recruiting, targeting 33 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision * IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). * Injection will take place into the proximal humerus
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).