What is the Purpose of this Study?

The purpose of this study is to compare 2 treatments for patients with severe open lower leg fractures to determine which is better at preventing infection after surgery. Participants will be randomly assigned to 1 of 2 treatment groups. In the first group, 2 antibiotics (vancomycin powder and tobramycin powder) will be mixed with calcium sulfate powder and placed in the bone before it is fixed with the intramedullary nail (surgical procedure in which a metal rod is inserted into the bone). The second group will receive a standard-of-care intramedullary nail without antibiotics inside the bone. Participants will be asked to complete follow-up visits and surveys about physical function, pain, return to work, and quality of life. Vancomycin and tobramycin are approved by the U.S. Food and Drug Administration (FDA) but have not been approved for administration by the route used in this study.

Eligibility

Where can I participate?