Vancomycin in Spine Surgery

Status unconfirmed · Phase 4

Conditions studied: Wound Infection

In brief

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.

Key facts

Study ID: NCT01977989
Run by: University of Tennessee
People needed: 140
Starts: 2013-10-01
Expected to finish: 2015-10-01
Last updated by the study team: 2013-11-07

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Hemodynamically stable
18 years of age or older
Undergoing spinal fusion for traumatic cervical, thoracic, or lumbar injury

You may not qualify if…

Septic patient
Open or penetrating spinal injury
Active infection
Active cancer
Known allergy to vancomycin
Previous surgery in surgical site
History of radiation therapy at surgical site
Immunosuppressed (disease or drug-induced)

Where it is running

Regional Medical Center (The MED) — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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