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. © 2004 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 70B: 114–121, 2004