S. Aravind1,2, F. Fabian3, R. Spretz3, U. R. Yanala1,2, J. Ragusa3, A. E. Ismail3, G. Larsen ?3, W. Velander3, M. A. Carlson1,2 1University Of Nebraska College Of Medicine,General Surgery,Omaha, NE, USA 2VA Medical Center,General Surgery,Omaha, NE, USA 3University Of Nebraska – Lincoln,Bio-Medical Engineering,Lincoln, NE, USA
Introduction:
In this study we evaluated the acute efficacy of a hemostatic patch consisting of custom-made nano-engineered resorbable polycaprolactone (PCL) mesh embedded with human clotting factors in a nonsurvival porcine model of hepatic resection. Our overall goal with this work has been to develop a synthetic resorbable biologics-supplemented bandage for surgical bleeding.
Methods:
Normovolemic normothermic domestic swine (male, N = 51, ~3 months, 33–40 kg) were anesthetized and splenectomized before they underwent nonanatomical scissor resection of the left medial liver lobe. Subjects were randomized among four treatment groups: group 1 (control) = cautery + suture ligation + Surgicel® application; group 2 = PCL mesh alone (16 x 8cm, six-ply); group 3 = PCL with fibrin sealant (FS = human plasma-derived fibrinogen (pdFI) + human recombinant thrombin (rFII) + human recombinant Factor XIII (rFXIII)); group 4 = PCL with rFII + rFXIII only. Test bandages were applied with 5 min of bimanual compression. Resuscitation was administered with warm Lactated Ringer's solution (10 mL/min; given for MAP <80% of pre-injury MAP). Subjects underwent vital sign monitoring and blood testing for 60 min, then necropsy with blood loss quantification.
Results:
Pre-injury parameters (subject weight, vital signs, preparation blood loss, and baseline laboratory tests) were not different among the treatment groups. One anesthetic death occurred in group 3, leaving 50 subjects for analysis (Table 1). Blood loss was different among groups, with group 3 and 4 having the highest and lowest blood loss, respectively. Final plasma fibrinogen level also was different, with group 4 having the highest. Final MAP, hemoglobin, and protime were not different among the groups.
Conclusion:
Resorbable PCL mesh, either alone or in combination with rFII + rFXIII, appeared to have at least equivalent hemostatic efficacy (with respect to 1 h blood loss) compared with traditional surgical technique in this model of porcine hepatic resection. Additional preclinical testing (including efficacy in different hemorrhage models, and toxicology) is planned.
