IO Vancomycin in TSA
Shoulder Injuries
About this trial
This is an interventional treatment trial for Shoulder Injuries focused on measuring total shoulder arthroplasty
Eligibility Criteria
Inclusion Criteria Patient is undergoing anatomic or reverse shoulder arthroplasty Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study Age Range >18 Exclusion Criteria: Previous shoulder surgery BMI above 35 Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc). Inability to administer the IO infusion Refusal to participate Diabetes Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)
Sites / Locations
- Houston Methodist HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Control - Standard IV administration of vancomycin
Intervention - Intraosseous (IO) 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).
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