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Antibiotic

Vancomycin in Spine Surgery

Phase 4
Waitlist Available
Research Sponsored by University of Tennessee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group

Summary

The purpose of this study is to study how well using a powdered form of the antibiotic, vancomycin, inside the surgery wound prevents infection in patients undergoing instrumented spinal surgery for traumatic injury to the back. Vancomycin is approved by the United States Food and Drug Administration (FDA) for treating certain kinds of bacteria. It is also used to prevent infections of the surgery site. This will be a study in which the experimental treatment is compared to a standard (control) treatment. It will be prospective in nature, meaning that it will follow patients forward in time, and it will consist of a randomization process to determine who will receive the experimental treatment versus the standard (control) treatment. The study will take place at Regional Medical Center (The MED). 140 subjects will be participating in this study. The investigators hypothesize that the topical use of powder vancomycin will decrease the rate of surgical site infection.

Eligible Conditions
  • Infected Wounds
  • Wound Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgical Site Infection

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: No Vancomycin PowderActive Control1 Intervention
Patients who only receive IV Vancomycion prior to surgery. No Vancomycin powder is administered.
Group II: Vancomycin PowderActive Control1 Intervention
Patients who receive Vancomycin powder in the surgical site following surgery.

Find a Location

Who is running the clinical trial?

University of TennesseeLead Sponsor
198 Previous Clinical Trials
144,570 Total Patients Enrolled
Semmes-Murphey FoundationOTHER
2 Previous Clinical Trials
1,030 Total Patients Enrolled
~11 spots leftby Jan 2026
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