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.