This study focuses on adults (18-80 years old) who have a severe lower leg/ankle fracture that will be treated with a screw and plate procedure. The purpose of the study is to help identify the best treatment for severe lower leg injuries. Researchers aim to determine whether a combination of antibiotic drugs called vancomycin and tobramycin is better than vancomycin alone at preventing infection after surgery to fix severe lower leg or ankle fractures. Previous studies have shown that using antibiotics like vancomycin and tobramycin in a powder form sprinkled in the site of surgery can lead to a smaller risk for infection later. The Food and Drug Administration (FDA) has permitted the use of these drugs in powder form. Participants will be randomly assigned to 1 of 2 groups. One group will receive vancomycin powder only, and the other will receive a mix of vancomycin with tobramycin powders sprinkled into the surgical incision. All participants will receive standard-of-care treatment for their injury.
What is the full name of this clinical trial?
Topical Antibiotic Therapy to Reduce Infection after Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial