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Novel Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA-A Multicenter RCT
[Technical Report, Annual Report]
MARYLAND UNIV BALTIMORE
Pagination or Media Count:
Background Infection after treatment of high-energy military fractures is very common and continues to cause significant morbidity. Recently, a study showing the use of local vancomycin powder around metal hardware used to treat these at-risk fractures results in a reduced risk of infection. The powder is thought to create a kill zone around the metal, prevent bacterial colonization, and therefore reduce the rate of postoperative infection. Specific Aims Our primary specific aim is to demonstrate that the infection rate defined by CDC criteria is lower in patients with at-risk fractures treated with standard of care as well as local vancomycin and tobramycin than patients treated with standard of care and vancomycin alone. Additional specific aims include investigation of the potential development of antibiotic resistance and examining bacterial sensitivities in patients who become infected in the treatment group and comparing the proportion of additional complications such as wound dehiscence and nonunion. Study Design The proposed study is a multi-center prospective open label randomized controlled trial. The study will accumulate patients from 50 core civilian and 1 military center to ensure generalizability. The study group will be a a set of tibial plateau and pilon fractures previously shown to be at high risk of infection treated with plate and screw fixation. 1900 participants 950 per treatment arm will be enrolled from METRC trauma centers over 24 months. Participants will be recruited during hospitalization for the initial injury. Military Benefit and Clinical Impact Infection is a very common and serious complication associated with the treatment of high-energy military extremity trauma.
[A, Approved For Public Release]