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  • Title: Evaluation of pooled fibrin sealant for ear surgery.
    Author: Siedentop KH, Chung SE, Park JJ, Sanchez B, Bhattacharya T, Marx G.
    Journal: Am J Otol; 1997 Sep; 18(5):660-4. PubMed ID: 9303166.
    Abstract:
    HYPOTHESIS: This study investigated the bonding strength and tissue toxicity of a commercially prepared dual-virally-inactivated pooled-blood fibrin tissue adhesive (ViGuard-FS; Melville Biologics, Inc., NY, U.S.A.) and compared it with an autologous fibrin tissue adhesive made by the precipitation of fibrinogen using ethanol and freezing (AFTA-E). METHODS: The bonding strength of FS was optimized by varying the concentrations of fibrinogen and human or bovine thrombin using three different surface media: inorganic (silastic), animal skin, and human dura mater. Furthermore, tissue reactions and duration of fibrin clots were studied by injecting FS into the auricles of rats. RESULTS: This study showed that optimized FS with human thrombin was superior in bonding strength to AFTA-E on all three surface media, and that FS does not produce any toxic tissue responses when injected into rat auricles. Minimal traces of the adhesive clot could be observed in a few auricles at 35 days after application. CONCLUSIONS: Because it is made from pooled-donor blood that has been treated with virus elimination procedures, FS is superior to autologous fibrin tissue adhesive in which fibrinogen 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 clinical development of ViGuard-FS as a tissue adhesive for otologic surgery.
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