Comparative analyses of the hemostatic efficacy and surgical device performance of powdered oxidized regenerated cellulose and starch-based powder formulations
M. Stark, Allen Y. Wang, Brittny Corrigan, Henok G. Woldu, Samar Azizighannad, Gustavo Cipolla, Richard Kocharian, Héctor De León
Abstract
Background Hemostatic powders offer unique therapeutic advantages over other formulations, including ease of application and rapid distribution over large bleeding surfaces. The efficacy of powder-based hemostats is dependent on device performance, which is rarely investigated independently from efficacy. Objectives The current study aimed to compare the hemostatic efficacy of an oxidized regenerated cellulose agent (Surgicel, Ethicon, Inc) and 3 starch-based biopolymers (Arista, Becton Dickinson; PerClot, Baxter International; and 4DryField, PlantTec Medical GmbH) and the performance of their delivery device applicators. Methods Efficacy was evaluated in a porcine model of bleeding using 2 study designs where the powder was delivered with (experiment 1) and without (experiment 2) device applicators. Device performance (powder expression) was examined in vitro at 3 device positions/angles: 90° (vertical, downward), 45° (slanted, downward), and 180° (horizontal). Results Surgicel efficacy rate was noninferior ( P ≤ .0002) and superior ( P ≤ .004) to that of any of the 3 starch-based agents regardless of whether the powder was delivered with their devices (experiment 1) or directly applied onto the bleeding sites (experiment 2). Surgicel required fewer applications ( P ≤ .0002) and less powder ( P < .0001) to achieve hemostasis. The Surgicel device was the only one that consistently delivered precise amounts of powder over a critical range of applications in the 3 positions tested. Conclusion The oxidized regenerated cellulose powder was the most efficacious hemostat, and the Surgicel applicator exhibited the highest performance compared with any of the 3 starch-based devices investigated. The current study highlights the relevance of combining high-efficacy powder hemostats with innovative, high-performance applicators to effectively manage bleeding control in surgical settings.