IO Vancomycin Spine

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Lumbar Fusion Surgery

Treatments: Drug: Intravenous Vancomycin; Drug: Intraosseous Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT06748144

PRO00038766

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Intraosseous Vancomycin

Experimental group

Description:

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.

Treatment:

Drug: Intraosseous Vancomycin

Intravenous Vancomycin

Active Comparator group

Description:

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).

Treatment:

Drug: Intravenous Vancomycin