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NCT06748144 | NOT YET RECRUITING | Lumbar Fusion Surgery

IO Vancomycin Spine
Sponsor:

The Methodist Hospital Research Institute

Information provided by (Responsible Party):

Mark broadcasting

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.

Condition or disease

Lumbar Fusion Surgery

Intervention/treatment

Intraosseous Vancomycin

Intravenous Vancomycin

Phase

PHASE2

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : SINGLE
Primary Purpose : PREVENTION
Official Title : Intraosseous Vs. Intravenous Vancomycin Administration in Spine Surgery
Actual Study Start Date : 2025-04
Estimated Primary Completion Date : 2027-04
Estimated Study Completion Date : 2030-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
IO Vancomycin Spine

Location Details

NCT06748144

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

Houston Methodist Hospital

Houston, Texas, United States, 77030