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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intraosseous Vancomycin
DrugThe 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
DrugThis is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Intraosseous VancomycinExperimental treatment 1 intervention
Group B: Intravenous VancomycinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Level of Systemic Vancomycin Concentration
The level of vancomycin concentration will be assessed via a blood draw by the anesthesiologist staff.
Time frame
Start of skin incision during surgery, Start of closure of skin incision during surgery2
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.
Time frame
During surgery3
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.
Time frame
During surgerySecondary outcomes
1
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.
Time frame
30 Days Post Surgery, 90 Days Post SurgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: