U. R. Yanala1,2, S. Noriega3, R. Spretz3, J. Ragusa3, L. Nunez3, G. Larsen3,4, M. A. Carlson1,2 1University Of Nebraska Medical Center,Surgery,Omaha, NE, USA 2Veteran Affairs Medical Center,Surgery,Omaha, NE, USA 3LNK Chemsolutions,Lincoln, NE, USA 4University Of Nebraska,Chemical & Biomolecular Engineering,Lincoln, NE, USA
Introduction: Commercially-available topical hemostats for minor hemorrhage incurred during elective surgical procedures are relatively expensive. We believe that more economical synthetic hemostats could be produced. Our objective here was to compare the efficacy and toxicity of a synthetic resorbable hemostatic bandage vs. an analogous commercial product in a porcine model of minor hemorrhage.
Methods: For the nonsurvival efficacy study, anesthetized domestic swine (boars, 3 months, 29-40 kg) underwent arterial/venous line placement and splenectomy. A 1 x 8 cm section of liver was resected from the edge of the left lateral lobe, and test bandage (macroporous polycaprolactone mesh, PCL; N = 10) or oxidized regenerated cellulose (ORC; Surgicel®, Ethicon®; N = 10) was applied with manual pressure for 5 minutes. Resuscitation then was performed with warm LR (target MAP = 80% of preinjury), and blood loss was measured 60 min after injury. For the survival toxicity study, a similar resection technique was employed (N = 6 for each material), and necropsy was performed at 30 days to evaluate for bandage toxicity (subject growth, serum chemistry, histology).
Results: Pre-injury weight, VS, and laboratory testing did not differ among groups. Resection mortality was zero. In the efficacy study, there were no differences between the PCL vs. ORC groups in blood loss or other post-injury variables (Table), except that the resuscitation fluid volume in the ORC group was greater. Other results from the efficacy study not shown in the Table include platelet counts and coagulation testing (no significant differences). Other than minor granuloma formation at the implantation site with both PCL and ORC, the survival study did not reveal any measurable toxicity.
Conclusion: The efficacy and toxicity of the PCL test bandage vs. the ORC comparator were not different in a porcine model of minor hepatic hemorrhage. Based on projected costs of production (not shown), the PCL bandage could represent a lower-cost alternative to ORC for the treatment of minor surgical bleeding.
