Novel Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA-A Multicenter RCT

Study Objective The overall objective is to compare the effect of vancomycin powder (control) to vancomycin and tobramycin powder combined (treatment) in the reduction of post-fixation infections of the tibial plateau and tibial pilon fractures at high risk of infection. Scope of Work The Sub-Recipient is being contracted to screen and enroll patients into the TOBRA trial based on the specific eligibility criteria defined in the trial protocol. The initial contract will be one-year in length and will be reviewed for up to four years (the TOBRA clinical trial duration). Under the Sub-Contract Agreement, the Sub-Recipient will be required to: • Obtain institutional review board (IRB) approval for the study protocol provided by the METRC Coordinating Center through the services of the study''s single IRB provider (Pearl IRB). • Obtain Department of Defense Human Research Protections Office (DoD HRPO) approval. • Participate in all required training on the study protocol and procedures. • Obtain METRC Coordinating Center certification. • Maintain up-to-date master study documents, including the protocol, standard operating procedures, informed consent, and case report forms (these are available by login on the METRC website). • Maintain up-to-date local study documents, including standard operating procedures, the delegation of authority logs, screening and enrollment logs, and event report documentation, as required by the METRC Coordinating Center or by the IRB of record. • Screen all patients between the ages of 18 and 80 years (inclusive) with a tibial plateau or tibial pilon fracture in close collaboration with the surgeon investigators. Screening 3 should typically occur during the initial hospitalization following injury but prior to definitive fixation surgery. A screening case report forms (CRFs) will be completed on every potentially eligible participant and entered into REDCap, the METRC electronic data capture system, in order to document screening results. • Obtain and document Informed Consent, using appropriate/approved Informed Consent Forms from eligible patients who agree to participate. • For enrolled patients, collect and enter baseline data into the REDCap database. • Evaluate participants at study visits scheduled at enrollment (1-2 weeks post-fracture) and then at follow up (after 3-, 6-, and 12-months post-injury). The Sub-Recipient is responsible for completing the appropriate CRFs for each visit and entering the follow-up data into the REDCap database. • Respond to missing or incomplete data queries from the METRC Coordinating Center. • Compensate participants $20 for completing the 6-month follow up visit and $20 for completing the 12-month follow-up visit.