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NCT Number: NCT06748144

IO Vancomycin Spine

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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Key information

Conditions

Lumbar Fusion Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Level of Systemic Vancomycin Concentration

    Time frame: 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.

  2. Level of Vancomycin Concentration in Bone

    Time frame: 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.

  3. Level of Vancomycin Concentration in Soft Tissue

    Time frame: During surgery

    Soft tissue samples (Multifidus muscle, Fat) will be taken during surgery to assess levels of vancomycin concentration in the tissue.

Secondary outcomes

  1. Post-Operative Complication Rates

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Vidal

CONTACT

[email protected]

346-238-4675

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Intraosseous vs. Intravenous Vancomycin Administration in Spine Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Dec 27, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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