Not Yet RecruitingPhase 2/3

IO Vancomycin Spine

United States30 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Level of Systemic Vancomycin Concentration

Timeframe: Start of skin incision during surgery, Start of closure of skin incision during surgery

Level of Vancomycin Concentration in Bone

Timeframe: During surgery

Level of Vancomycin Concentration in Soft Tissue

Timeframe: During surgery

Trial details

NCT IDNCT06748144

SponsorThe Methodist Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Emily Vidal

346-238-4675 evidal@houstonmethodist.org