IO Vancomycin Spine

Phase 2

Not yet recruiting

• Conditions: Lumbar Fusion Surgery
• Interventions: Drug: Intraosseous Vancomycin; Drug: Intravenous Vancomycin

• Registration Number: NCT06748144
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-04
• Primary Completion: 2027-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient is undergoing open posterior instrumented spinal fusion (PSIF) or transforaminal lumbar interbody fusion (TLIF)
• Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study
• Age Range >18

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Exclusion Criteria

• Previous spine surgery if surgeon deems it will affect the study
• BMI > 40
• 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 as defined as uncontrolled A1C > 7.5 and eGFR <59
• Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)
• No vulnerable populations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraosseous Vancomycin	Intraosseous Vancomycin	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.
Intravenous Vancomycin	Intravenous Vancomycin	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).

Primary Outcome Measures

Name	Time	Method
Change in Level of Systemic Vancomycin Concentration	Start of skin incision during surgery, Start of closure of skin incision during surgery	The level of vancomycin concentration will be assessed via a blood draw by the anesthesiologist staff.
Level of Vancomycin Concentration in Bone	During surgery	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.
Level of Vancomycin Concentration in Soft Tissue	During surgery	Soft tissue samples (Multifidus muscle, Fat) will be taken during surgery to assess levels of vancomycin concentration in the tissue.

Secondary Outcome Measures

Name	Time	Method
Post-Operative Complication Rates	30 Days Post Surgery, 90 Days Post Surgery	Participant's charts will be reviewed postoperatively to determine if there were any adverse local/systemic reactions and/or complications following the surgery.

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States