Medical Devices: Evidence and Research (Jun 2023)
Efficacy of Flowable Collagen Hemostat Evaluated in Preclinical Models of Liver Injury and Spinal Cord Exposure
Abstract
Spencer P Lake,1 Kasia Bradbury,2 Darcy H Gagne,2 Corey R Deeken,3 Amit Badhwar,2 Angela Bohnen4 1Department of Mechanical Engineering & Materials Science, Washington University in St. Louis, St. Louis, MO, USA; 2Becton, Dickinson and Company, Warwick, RI, USA; 3Covalent Bio, LLC, St. Louis, MO, USA; 4Neurosurgery One, Littleton, CO, USACorrespondence: Amit Badhwar, Becton, Dickinson and Company (BD), 100 Crossings Boulevard, Warwick, RI, 02886, USA, Tel +1 401 825-8514, Fax +1 401 825-8762, Email [email protected]: Excessive bleeding in trauma and surgical settings leads to increased operative time, reoperation rates, and overall healthcare costs. A wide range of hemostatic agents have been developed to control bleeding that can vary considerably in type of hemostatic action, ease of application, cost, risk of infection, and dependence on patient coagulation. Microfibrillar collagen-based hemostatic materials (MCH) have yielded beneficial results in a variety of applications.Methods: A new flowable collagen product, containing a modified MCH flour, but in a more convenient flowable delivery system, was evaluated for hemostatic efficacy in preclinical models of solid organ injury and spinal cord exposure. The primary objective of this study was to compare the hemostatic potential and local tissue responses to this novel, flowable collagen-based hemostatic agent to the original flour formulation to confirm that the new method of delivery did not interfere with the hemostatic properties of the MCH flour.Results: When observed visually, the flowable MCH flour mixed with saline (FL) provided more precise application and uniform coverage to injured tissues compared to the dry MCH flour alone (F0). All of the treatments (FL, F0, and gauze) exhibited comparable Lewis bleed grade at all three time points evaluated in the capsular resection liver injury model (bleed grade: 1.0– 1.3; p> 0.05 in all cases). FL and F0 exhibited comparable 100% acute hemostatic efficacy and similar long-term histomorphological properties (up to 120 days) in a capsular resection liver injury in pigs, while gauze resulted in significantly lower rates of acute hemostatic efficacy (8– 42%, p< 0.05 in all cases). In an ovine model of dorsal laminectomy and durotomy, FL and F0 again exhibited comparable results without any neurological effects.Conclusion: Flowable microfibrillar collagen was shown to yield favorable short- and long-term outcomes in two representative applications where hemostatic efficacy is critical to surgical success.Keywords: hemostatic agent, bleeding, microfibrillar collagen, liver injury, spine surgery
