title: Hemostatic efficacy of EVARREST™, Fibrin Sealant Patch vs. TachoSil® in a heparinized swine spleen incision model.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  This 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.
  
  
  METHODS
  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.
  
  
  RESULTS
  At 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.
  
  
  CONCLUSIONS
  EVARREST™, 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.
authors.affiliation: 1Preclinical Research, Ethicon, Inc., Somerville, New Jersey, USA.
authors.forename: John P
authors.initials: JP
authors.lastname: Matonick
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Hammond
mesh_terms: D000818:Animals; D000925:Anticoagulants / Q000008:administration & dosage* / Q000494:pharmacology; D001777:Blood Coagulation / Q000187:drug effects; D002482:Cellulose / Q000494:pharmacology / Q000627:therapeutic use; D003094:Collagen / Q000494:pharmacology / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000494:pharmacology / Q000627:therapeutic use*; D005340:Fibrinogen / Q000494:pharmacology / Q000627:therapeutic use*; D006488:Hemostasis, Surgical / Q000379:methods*; D006490:Hemostatics / Q000494:pharmacology / Q000627:therapeutic use*; D006493:Heparin / Q000008:administration & dosage* / Q000494:pharmacology; D008297:Male; D023421:Models, Animal; D013154:Spleen / Q000601:surgery*; D013552:Swine; D013917:Thrombin / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D000925:Anticoagulants; D004338:Drug Combinations; D015718:Fibrin Tissue Adhesive; D006490:Hemostatics; C518955:TachoSil; D005340:Fibrinogen; D002482:Cellulose; D006493:Heparin; D003094:Collagen; D013917:Thrombin
keywords: EVARRESTTM, Fibrin Sealant Patch; ORC; TachoSil®; hemostasis; oxidized regenerated cellulose; polyglactin 910