title: Structural design of the dry fibrin sealant dressing and its impact on the hemostatic efficacy of the product.
abstract: We compared the hemostatic efficacy of a production version of a dry fibrin sealant dressing (DFSD) to a prototype that was previously successful in large animal studies. The results were used to improve manufacturing processes. Grade-V liver injuries were induced in swine and treated with gauze sponges (GAU), the prototype dressings (DFSD-1), or the scaled-up production version dressings (DFSD-2 in experiment 1 and DFSD-3 in experiment 2). Blood loss, hemostasis, resuscitation volume, and 60-min survival were quantified. In experiment 1, the DFSD-1 treatment reduced blood loss (p < 0.01), increased hemostasis at 4 min (p < 0.05), and improved survival (p < 0.05) compared with GAU. The DFSHD-2 decreased blood loss (p < 0.05) but did not increase hemostasis or survival significantly. Based on these results, manufacturing processes were altered, producing DFSD-3. In experiment 2, the DFSD-1 and DFSD-3 were equally effective in reducing blood loss (p < 0.01) and resuscitation volume (p < 0.05) compared with GAU. Hemostasis occurred more frequently in both the DFSD-1 and DFSD-3 groups (p < 0.01) compared with GAU. The structural design of DFSD-2 did not meet the efficacy requirement for release of the product. The subsequent change incorporated in DFSD-3 improved all hemostatic parameters of the dressings equal to those of the prototype product.
authors.affiliation: US Army Institute of Surgical Research, Fort Sam Houston, San Antonio, Texas 78234-6315, USA.
authors.forename: Anthony E
authors.initials: AE
authors.lastname: Pusateri
authors.forename: Bijan S
authors.initials: BS
authors.lastname: Kheirabadi
authors.forename: Angel V
authors.initials: AV
authors.lastname: Delgado
authors.forename: James W
authors.initials: JW
authors.lastname: Doyle
authors.forename: Jerry
authors.initials: J
authors.lastname: Kanellos
authors.forename: John M
authors.initials: JM
authors.lastname: Uscilowicz
authors.forename: Raul S
authors.initials: RS
authors.lastname: Martinez
authors.forename: John B
authors.initials: JB
authors.lastname: Holcomb
authors.forename: Harold E
authors.initials: HE
authors.lastname: Modrow
mesh_terms: D000818:Animals; D001458:Bandages; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000737:chemistry / Q000378:metabolism*; D006470:Hemorrhage / Q000517:prevention & control; D006487:Hemostasis; D006490:Hemostatics / Q000737:chemistry / Q000378:metabolism*; D006801:Humans; D008099:Liver / Q000293:injuries / Q000473:pathology; D008297:Male; D011897:Random Allocation; D012151:Resuscitation; D013552:Swine
chemical_list: D015718:Fibrin Tissue Adhesive; D006490:Hemostatics