Prophylactic Antibiotic-Coated Nail to Prevent Infection: A Clinical Trial
Abstract:
Open tibia fractures are severe and common injuries sustained by Wounded Warriors in combat. Osteomyelitis and deep infection are unfortunately common after severe open fractures. Rates of infection following high-energy open fractures range from 6-40 percent. Furthermore, the injury mechanisms associated with the military involving penetrating fragments contribute to a higher rate of infection as compared to the civilian sector, in which blunt trauma is more common. To date, the field of orthopaedic surgery has not experienced a significant reduction in infection rates, despite numerous studies of a variety of different treatment options. Therefore, any novel strategy to reduce infection warrants rigorous study. The goal of this study is to investigate a potential treatment for serious open tibia fractures which are likely to become infected. Usually, these injuries are treated with a nail without antibiotic coating. The other treatment option is to use anantibiotic-coated nail (vancomycin, tobramycin and gentamicin). Antibiotic coated nails are commonly used for patients who have an infection. Using an antibiotic coated nail for prevention would be an extension of this practice. This study will compare infection rates among patients treated with an antibiotic coated nail and people treated with a standard of care nail (nail without antibiotic coating). The study addresses the FY20 PRORP CTA Focus Area of fracture-related infection, specifically prevention of infection. The study will include patients with severe open tibia fractures because these injuries are at very high risk of infection. By preventing infection in these patients, we can avoid readmissions, reoperations, and extended antibiotic regimens. In addition, a reduction in infection rate will mean patients will be able to return to work orduty and have lower rates of disability.