Lumbar Fusion Surgery
Conditions
Brief summary
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.
Interventions
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.
This is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Level of Systemic Vancomycin Concentration | Start of skin incision during surgery, Start of closure of skin incision during surgery | The level of vancomycin concentration will be assessed via a blood draw by the anesthesiologist staff. |
| Level of Vancomycin Concentration in Bone | During surgery | 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. |
| Level of Vancomycin Concentration in Soft Tissue | During surgery | Soft tissue samples (Multifidus muscle, Fat) will be taken during surgery to assess levels of vancomycin concentration in the tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Complication Rates | 30 Days Post Surgery, 90 Days Post Surgery | Participant's charts will be reviewed postoperatively to determine if there were any adverse local/systemic reactions and/or complications following the surgery. |
Countries
United States
Contacts
CONTACTEmily Vidal
Outcome results
None listed