Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2023-01-25
2024-01-25
Brief Summary
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Detailed Description
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Secondary Objective: Compare 30- and 90-day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) versus the interventional group (intraosseous administration of vancomycin). The research team hypothesizes that there will be no difference in complication (infection) rates between groups
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
* Lab will be blinded to which group subject samples come from when doing concentration level testing.
Study Groups
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Intravenous Vancomycin Administration
Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty 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 \[12,13\] generally 1000-1750mg in 500mL NS).
Intravenous Vancomycin
IV 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 NS).
Intraosseous Vancomycin Administration
* 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 administered preoperatively in this group.
* IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).
* Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.
Intraosseous Vancomycin Injection
• IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).
Interventions
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Intraosseous Vancomycin Injection
• IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).
Intravenous Vancomycin
IV 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 NS).
Eligibility Criteria
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Inclusion Criteria
* Patient is able to understand the study design and intervention and gives informed consent to participate in the study. No LAR consents will be utilized for this study.
* Age \>18 years.
* Total knee arthroplasty performed without the use of a tourniquet.
Exclusion Criteria
* BMI above 35
* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
* Inability to locate the tibial tubercle or administer the IO infusion
* Refusal to participate
* Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C \>7.5.
* Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)
19 Years
80 Years
ALL
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Responsible Party
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Timothy S. Brown
Principal Investigator
Locations
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Houston Methodist Hospital Outpatient Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Sonya Hadrigan
Role: primary
Other Identifiers
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PRO00035759
Identifier Type: -
Identifier Source: org_study_id