IO Vancomycin Spine

Conditions

• Lumbar Fusion Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

May 31, 2026

Status verified

Mar 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2030

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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.
• 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).

Primary Outcome Measure

Change in Level of Systemic Vancomycin Concentration [ Time Frame: Start of skin incision during surgery, Start of closure of skin incision during surgery ]

Central Contacts

• Emily Vidal
  346-238-4675
  [email protected]

Locations (1)

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