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The goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraosseous Vancomycin | Experimental | Participants in this group will receive other antibiotics according to the Houston Methodist Hospital orthopedic surgeon's standard of care regimen, which typically involves ancef or cefepime being administered in pre-op within 1 hour of the incision. IO Vancomycin will be administered in the OR after incision (500mg in 100-150mL normal saline (NS)), and the injection will be placed into the posterior ilium. |
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| Intravenous Vancomycin | Active Comparator | Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for lumbar fusion patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin), which 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraosseous Vancomycin | Drug | The intervention is specific to the method of administration that will be used when giving the dose of antibiotic vancomycin which is done to prevent infection following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Level of Systemic Vancomycin Concentration | The level of vancomycin concentration will be assessed via a blood draw by the anesthesiologist staff. | Start of skin incision during surgery, Start of closure of skin incision during surgery |
| Level of Vancomycin Concentration in Bone | Bony tissue samples (Superior Articular Process, Inferior Articular Process, and Lamina) will be taken during surgery to assess levels of vancomycin concentration in the bone. | During surgery |
| Level of Vancomycin Concentration in Soft Tissue | Soft tissue samples (Multifidus muscle, Fat) will be taken during surgery to assess levels of vancomycin concentration in the tissue. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Complication Rates | Participant's charts will be reviewed postoperatively to determine if there were any adverse local/systemic reactions and/or complications following the surgery. | 30 Days Post Surgery, 90 Days Post Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Vidal | Contact | 346-238-4675 | evidal@houstonmethodist.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
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| Intravenous Vancomycin | Drug | This is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection. |
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