IO Vancomycin Spine

Intraosseous vs. Intravenous Vancomycin Administration in Spine Surgery

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 Overview

• Status: Not yet recruiting
• Conditions: Lumbar Fusion Surgery
• Intervention / Treatment: Drug: Intraosseous Vancomycin; Drug: Intravenous Vancomycin

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Emily Vidal; Phone Number: 346-238-4675; Email: evidal@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
      • Contact: Emily Vidal; Phone Number: 346-238-4675; Email: evidal@houstonmethodist.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Intraosseous Vancomycin; 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.
Active Comparator: 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).	Drug: Intravenous Vancomycin; This is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Vancomycin
• Other Study ID Numbers: PRO00038766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No