drugset / Trial / NCT01977989

Vancomycin in Spine Surgery

NCT01977989

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2013-10
Primary completion
2015-10
Completion
2015-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vancomycin Other / unclassified 500 mg Topical
Comparator Vancomycin Other / unclassified 1 g Topical

Indications