Vancomycin in Spine Surgery

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Tennessee
• Collaborator: Semmes-Murphey Foundation
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• Hemodynamically stable

• 18 years of age or older

• Undergoing spinal fusion for traumatic cervical, thoracic, or lumbar injury

Exclusion Criteria:

• 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)