A research plan is described to establish the feasibility of using ion beam processes to reduce or eliminate pin tract infection in external fixation devices. A process will be developed for producing bacteriostatic, biocompatible surfaces. Anti-bacterial properties will be evaluated via in vitro microbial challenge tests; cytotoxicity and systemic injection tests will be used to screen biocompatibility. The in vivo efficacy of the coating will be evaluated by treating actual pins, implanting them into iliac crests of domestic sheep and comparing their performance to control pins. The pins will be retrieved and examined for bacterial colonization of several bacterial strains. These in vivo tests will lead the Phase l program into a Phase II study which will involve further analytical and bench-top testing as well as more comprehensive animal studies and/or clinical trials.
