• J Invest Surg · Dec 2014

    Hemostatic efficacy of EVARREST™, Fibrin Sealant Patch vs. TachoSil® in a heparinized swine spleen incision model.

    • John P Matonick and Jeffrey Hammond.
    • 1Preclinical Research, Ethicon, Inc., Somerville, New Jersey, USA.
    • J Invest Surg. 2014 Dec 1;27(6):360-5.

    BackgroundFirst-generation single-component hemostats such as oxidized regenerated cellulose (ORC), fibrin, collagen, and gelatin have evolved into second and third generations of combination hemostats.ObjectiveThis study compares two FDA approved products, EVARREST™, Fibrin Sealant Patch, a hemostat comprised of a matrix of nonwoven polyglactin 910 embedded in ORC coated with human fibrinogen and thrombin to TachoSil® medicated sponge, an equine collagen pad coated with human fibrinogen and thrombin.Materials And MethodsSwine were anticoagulated with heparin to 3X their baseline activated clotting time and a 15 mm long × 3 mm deep incision was made to create a consistent moderate bleeding pattern. Test material was then applied to the wound site and compressed manually for 3 min with just enough pressure to prevent continued bleeding. Hemostatic effectiveness was evaluated at 3 min and 10 min.ResultsAt 3 min, the hemostasis success rate was 86% in the EVARREST™ group and 0% in the TachoSil® group, p < .0001. The overall success rate at 10 min was 100% with EVARREST™ and 4% with TachoSil®, p < .0001. Adhesive failure, in which the test material did not stick to the tissue, occurred in 96% of TachoSil® sites. In contrast, 100% of the EVARREST™ applications adhered to the test site.ConclusionsEVARREST™, Fibrin Sealant Patch demonstrated greater wound adhesion and more effective hemostasis than TachoSil®. Adhesive failure was the primary failure mode for TachoSil® in this model.

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