IO Vancomycin Spine

Phase 3Not Yet RecruitingNCT06748144

The Methodist Hospital Research Institute30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Lumbar Fusion Surgery

Interventions

Intraosseous VancomycinDRUG

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.

Intravenous VancomycinDRUG

This is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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

Locations (1)

Houston Methodist Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Change in Level of Systemic Vancomycin Concentration

The level of vancomycin concentration will be assessed via a blood draw by the anesthesiologist staff.

Time frame: 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.

Time frame: 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.

Time frame: During surgery

Secondary Outcomes

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.

Time frame: 30 Days Post Surgery, 90 Days Post Surgery

Central Contacts

Emily Vidal

CONTACT

346-238-4675 evidal@houstonmethodist.org

Data from ClinicalTrials.gov

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