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IO Vancomycin in TSA
Sponsor: The Methodist Hospital Research Institute
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.
Official title: Intraosseous vs. Intravenous Vancomycin Administration in Total Shoulder Arthroplasty: Changing the Paradigm
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2023-06-01
Completion Date
2026-03-10
Last Updated
2025-09-22
Healthy Volunteers
No
Conditions
Interventions
Intervention - Intraosseous (IO) administration of vancomycin
* 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
Control - Standard IV administration of vancomycin
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).
Locations (1)
Houston Methodist Hospital
Houston, Texas, United States