IO Vancomycin Spine
ConditionLumbar Fusion Surgery
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intraosseous Vancomycin
- Intravenous Vancomycin
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov