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Evaluation of the Hemostatic Efficacy of Two Powdered Topical Absorbable Hemostats Using a Porcine Liver Abrasion Model of Mild to Moderate Bleeding.
MacDonald, Melinda H; Tasse, Laura; Wang, Daidong; Zhang, Gary; De Leon, Hector; Kocharian, Richard.
Afiliación
  • MacDonald MH; Ethicon, Inc, Johnson & Johnson, Somerville, New Jersey, USA.
  • Tasse L; NAMSA, Northwood, Ohio, USA.
  • Wang D; Cardiovascular and Specialty Solutions (CSS), Irvine, California, USA.
  • Zhang G; Ethicon, Inc, Johnson & Johnson, Somerville, New Jersey, USA.
  • De Leon H; Scientific Consultant, Athens, Georgia, USA.
  • Kocharian R; Ethicon, Inc, Johnson & Johnson, Somerville, New Jersey, USA.
J Invest Surg ; 34(11): 1198-1206, 2021 Nov.
Article en En | MEDLINE | ID: mdl-32928005
INTRODUCTION: Topical hemostatic agents, used alone or in combination, have become common adjuncts to manage tissue and organ bleeding resulting from trauma and surgical procedures. Oxidized regenerated cellulose (ORC) is one of the most commonly used adjunctive hemostatic agents. The aim of the present study was to compare the hemostatic efficacy of a novel ORC-based product, SURGICEL® Powder Absorbable Hemostat (Surgicel-P) to that of HEMOBLAST™ Bellows (Hemoblast-B), a collagen-based combination powder. METHODS: Using an established porcine liver abrasion model, we randomly tested Surgicel-P and Hemoblast-B in 60 experimental lesion sites (30 per product tested). Primary endpoints included hemostatic efficacy measured by absolute time to hemostasis (TTH) within 5 minutes. We also examined number of applications required to achieve hemostasis, and sustained hemostasis following saline irrigation of test sites that achieved hemostasis. RESULTS: Surgicel-P demonstrated significantly higher hemostatic efficacy and lower TTH (p < 0.01) than Hemoblast-B. Surgicel-P-treated lesion sites achieved hemostasis in 73.3% of cases following one product application vs. 3.3% of Hemoblast-B-treated sites. Of all sites that were assessed, hemostasis was achieved and sustained following irrigation at 93.3% of Surgicel-P-treated sites vs. 50.0% of Hemoblast-B-treated sites. The average number of Surgicel-P applications per site was 51% lower than the average number of applications used for Hemoblast-B. CONCLUSION: Surgicel-P provided more effective and sustained hemostasis and faster TTH than Hemoblast-B. Surgicel-P represents a novel clinical alternative to provide adjunctive control of diffuse mild and moderate bleeding. Surgicel-P combines an ORC powder formulation and a delivery system in a device that is particularly useful for application on large surfaces and difficult-to-access anatomical locations where application of other forms of topical hemostats may be impractical.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Hemostáticos Límite: Animals Idioma: En Revista: J Invest Surg Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Hemostáticos Límite: Animals Idioma: En Revista: J Invest Surg Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos