IO Vancomycin in TSA

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

July 15, 2024

Study Completion Date

March 10, 2026

Conditions
Shoulder Injuries
Interventions
DRUG

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"

DRUG

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).

Trial Locations (1)

77030

Houston Methodist Hospital, Houston

All Listed Sponsors
lead

The Methodist Hospital Research Institute

OTHER