Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient is undergoing total ankle arthroplasty.
• Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study
• Age Range \>18
Locations
United States
Texas
Houston Methodist Hospital
RECRUITING
Houston
Contact Information
Primary
Thomas C Sullivan, BS
tsullivan@houstonmethodist.org
346-238-1603
Backup
Blesson Varghese, BS
bvarghese6@houstonmethodist.org
713-441-3814
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 40
Treatments
Active_comparator: Intravenous Vancomycin
Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA patients. This includes IV antibiotics (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 generally 1000-1750mg in 500mL normal saline (NS))
Experimental: Intraosseous Vancomycin
IV antibiotics per physician's standard of care: Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be given preoperatively in this group.~IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).~IO Injection will take place into the medial malleolus.
Related Therapeutic Areas
Sponsors
Leads: The Methodist Hospital Research Institute