Medical Devices: Evidence and Research (Nov 2017)
An in vivo comparison of the efficacy of hemostatic powders, using two porcine bleeding models
Abstract
Melinda H MacDonald, Allen Y Wang, Jeffrey W Clymer, Richard W Hutchinson, Richard Kocharian Ethicon Inc., Somerville, NJ, USA Background: Usage of topical hemostatic agents in surgery is increasing, including use during minimally invasive procedures, and even for surgeries that have a low risk of bleeding complications. A novel product, Surgicel® Powder – Absorbable Hemostatic Powder (SP), made from oxidized regenerated cellulose (ORC) fabric, has been developed for adjunctive use in surgical procedures to assist in control of oozing bleeding over broad areas and where access could be difficult with a fabric ORC product. This study compares the new SP to other commercially available hemostatic powder products in two in vivo models.Methods: Hemostatic efficacy of SP was compared to two polysaccharide-based hemostats in a porcine liver punch biopsy model and to three polysaccharide-based hemostats and one non-regenerated oxidized cellulose hemostat in a porcine liver abrasion model. Primary outcomes measured were hemostatic efficacy, defined as hemostasis within 10 minutes of application, and time-to-hemostasis (TTH).Results: In the punch biopsy model, SP displayed significantly higher effective hemostasis rates than one of the polysaccharide hemostats (p=0.047) and faster TTH than both (p<0.001). In the liver abrasion model, SP had significantly higher effective hemostasis rates (p≤0.002) and faster TTH (p<0.001) than the other four hemostatic agents. The amount of powder applied within the ranges used did not appear to affect hemostatic efficacy.Conclusion: In both the liver punch biopsy model of mild to moderate bleeding and the liver abrasion model of mild but diffuse oozing, SP provided more effective hemostasis and faster TTH than other marketed hemostatic powders. The results from this in vivo study suggest that Surgicel Powder may be useful in clinical applications where control of oozing capillary, mild venous, and small arterial hemorrhage is required including bleeding in difficult-to-access locations. Keywords: hemostasis, oxidized regenerated cellulose, Surgicel, in vivo model of bleeding, hemostatic powder, absorbable hemostat, topical absorbable hemostat
