Hemostatic Efficacy of EVARREST™, Fibrin Sealant Patch vs. TachoSil® in a Heparinized Swine Spleen Incision Model. (1st December 2014)

• Record Type: Journal Article
• Authors: Matonick, John P.; Hammond, Jeffrey
• Is Part Of: Journal of investigative surgery. Volume 27:Number 6(2014:Dec.)
• Page Start: 360
• Page End: 365
• Publication Date: 2014-12-01
• Subjects: Surgery -- Research -- Periodicals; Research; Surgery; Surgical Procedures, Operative; 617.075
• DOI: 10.3109/08941939.2014.941444
• Languages: English
• ISSNs: 0894-1939

Abstract

<abstract> <title>ABSTRACT</title> <p> <italic>Background</italic>: First-generation single-component hemostats such as oxidized regenerated cellulose (ORC), fibrin, collagen, and gelatin have evolved into second and third generations of combination hemostats. <italic>Objective</italic>: This study compares two FDA approved products, EVARREST<sup>TM</sup>, 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. <italic>Materials and Methods</italic>: Swine 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. <italic>Results</italic>: At 3 min, the hemostasis success rate was 86% in the EVARREST<sup>TM</sup> group and 0% in the TachoSil® group, <italic>p</italic> < .0001. The overall success rate at 10 min was 100% with EVARREST<sup>TM</sup> and 4% with TachoSil®, <italic>p</italic> < .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<sup>TM</sup> applications adhered to the test site. <italic>Conclusions</italic>: EVARREST<sup>TM</sup>, 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.</p> </abstract>