IO Vancomycin Spine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraosseous Vancomycin, Intravenous Vancomycin.
- Who it may be relevant to
- Registry conditions: Lumbar Fusion Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraosseous vs. Intravenous Vancomycin Administration in Spine Surgery
Overview
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
- Drug Intraosseous Vancomycin
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. - Drug Intravenous Vancomycin
This is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection.
Primary outcome measures
- Change in Level of Systemic Vancomycin Concentration [Time frame: Start of skin incision during surgery, Start of closure of skin incision during surgery]
- Level of Vancomycin Concentration in Bone [Time frame: During surgery]
- Level of Vancomycin Concentration in Soft Tissue [Time frame: During surgery]
Secondary outcome measures (1)
- Post-Operative Complication Rates [Time frame: 30 Days Post Surgery, 90 Days Post Surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Houston Methodist Hospital — Houston
Identifiers
NCT: NCT06748144 · PRO00038766