ABSTRACT
Fibrin sealant (FS) has been used successfully in a number of head and neck surgical indications, incorporating microsurgical techniques, in particular otology and neurotology. Patient autologous FS produced by cryoprecipitation quickly demonstrated shortcomings in certain performance characteristics, specifically cohesive and adhesive strength as well as low viscosity prior to polymerization (gelation). A pilot, human clinical trial was conducted to evaluate the utility and efficacy of two composite tissue adhesive (CTA) formulations. Human clinical trials included thirty patients undergoing a variety of otologic and neurotologic procedures. For otologic procedures, the impact of CTA in the reconstruction and replacement of bony elements as well as improvement in hearing performance was evaluated. There was no obvious difference in clinical performance between the two formulations. The pilot evaluation of CTA for neurologic and otologic procedures demonstrated the utility, flexibility, and efficacy of the fibrin-based technology in a number of different clinical indications.
