EVALUATION OF POOLED FIBRIN SEALANT FOR EAR SURGERY

Hypothesis: This study investigated the bonding strength and tissue to xicity of a commercially prepared dual-virally-inactivated pooled-bloo d fibrin tissue adhesive (ViGuard-FS; Melville Biologics, Inc., NY, U. S.A.) and compared it with an autologous fibrin tissue adhesive made b y the precipitation of fibrinogen using ethanol and freezing (AFTA-E). Methods: The bonding strength of FS was optimized by varying the conc entrations of fibrinogen and human or bovine thrombin using three diff erent surface media: inorganic (silastic), animal skin, and human dura mater. Furthermore, tissue reactions and duration of fibrin clots wer e studied by injecting FS into the auricles of rats. Results: This stu dy showed that optimized FS with human thrombin was superior in bondin g strength to AFTA-E on all three surface media, and that FS dots not produce any toxic tissue responses when injected into rat auricles. Mi nimal traces of the adhesive clot could be observed in a few auricles at 35 days after application. Conclusions: Because it is made from poo led-donor blood that has been treated with virus elimination procedure s, FS is superior to autologous fibrin tissue adhesive in which fibrin ogen is precipitated by the ethanol/freezing method. FS has not shown any undesirable tissue reactions when injected into live rat auricles. We believe that these results provide a rationale for further clinica l development of ViGuard-FS as a tissue adhesive for otologic surgery.