title: Swelling, sealing, and hemostatic ability of a novel biomaterial: A polyethylene glycol-coated collagen pad.
abstract: Trends in the development of hemostatic agents are towards self-adhering pads. This study investigates a novel biomaterial made of a polyethylene glycol-coated collagen pad (PCC). The swelling and adherence of PCC were investigated in vitro, and the hemostatic and sealing ability was investigated in vivo. In vitro, the maximum swell of PCC submerged in human plasma for 24 h is 65%. The greatest swell was in thickness, averaging 24% to a mean thickness of 2.5 ± 0.19 mm (mean±SD) (N = 20). PCC withstood clinically relevant pressures when applied to a collagen casing washed with bile, lymph, urine, saline, and cerebrospinal fluid mixed at 33% and 67% with blood. In vivo, PCC provided complete hemostasis when applied to severe, arterial bleeds of actively ventilated pulmonary parenchyma at 3, 5, 8, and 10 min after application in a heparinized porcine pulmonary segmentectomy model. The mean rate of bleeding was 17.7 ± 8.6 ml/min. The lungs were ventilated at 15 ± 4 breaths per min and an airway pressure of 19 ± 2 cm H2O. PCC had no incidence of hematoma and an 11% incidence of intraoperative air leak (N = 36). These data are promising for future clinical application of a new versatile, self-adhering hemostatic sealing pad consisting of a polyethylene glycol-coated collagen.
authors.affiliation: Baxter Healthcare Corporation, Deerfield, IL, USA kevin_lewis@baxter.com.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Lewis
authors.affiliation: Baxter Innovations GmbH, Vienna, Austria.
authors.forename: Daniel
authors.initials: D
authors.lastname: Spazierer
authors.affiliation: Ludwig Boltzmann Institute for Clinical and Experimental Traumatology in AUVA Research Center, Vienna, Austria.
authors.forename: Paul
authors.initials: P
authors.lastname: Slezak
authors.affiliation: Baxter Healthcare Corporation, Deerfield, IL, USA.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Baumgartner
authors.affiliation: Baxter Innovations GmbH, Vienna, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Regenbogen
authors.affiliation: Baxter Innovations GmbH, Vienna, Austria.
authors.forename: Heinz
authors.initials: H
authors.lastname: Gulle
mesh_terms: D000388:Air; D000818:Animals; D001158:Arteries / Q000473:pathology; D001672:Biocompatible Materials / Q000737:chemistry*; D002417:Cattle; D002448:Cell Adhesion; D003094:Collagen / Q000737:chemistry*; D006470:Hemorrhage; D006487:Hemostasis; D006490:Hemostatics / Q000737:chemistry*; D006801:Humans; D008168:Lung / Q000473:pathology; D008297:Male; D008422:Materials Testing; D011092:Polyethylene Glycols / Q000737:chemistry*; D011312:Pressure; D013552:Swine
chemical_list: D001672:Biocompatible Materials; D006490:Hemostatics; D011092:Polyethylene Glycols; D003094:Collagen
keywords: Evarrest; PEG-coated collagen pad; Tachosil; Veriset; hemopatch; in vitro adherence; in vitro swell