Structural design of the dry fibrin sealant dressing and its impact on the hemostatic efficacy of the product.
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.
Pusateri
Anthony E
AE
US Army Institute of Surgical Research, Fort Sam Houston, San Antonio, Texas 78234-6315, USA.
Kheirabadi
Bijan S
BS
Delgado
Angel V
AV
Doyle
James W
JW
Kanellos
Jerry
J
Uscilowicz
John M
JM
Martinez
Raul S
RS
Holcomb
John B
JB
Modrow
Harold E
HE
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
D015718:Fibrin Tissue Adhesive; D006490:Hemostatics