Pilot Study of a Novel Swine Model for Controlling Junctional Hemorrhage Using the iTClamp in Conjunction With Hemostatic Agents.

Abstract

Exsanguinating hemorrhage is a primary cause of battlefield death. The iTClamp is a relatively new device (FDA approval in 2013) that takes a different approach to hemorrhage control by applying mechanism wound closure. However, no previous studies have explored the feasibility of utilizing the iTClamp in conjunction with hemostatic packing. To fill this important gap in the literature, a novel swine model was developed, and a total of 12 trials were performed using QuikClot Combat Gauze or XSTAT sponges in conjunction with the iTClamp to treat arterial injuries through 5 cm or 10 cm skin incisions in the groin, axilla, or neck. First-attempt application success rate, application time, and blood loss were recorded. Hemostasis was achieved on all wounds, though reapplication was required in one Combat Gauze and three XSTAT applications. Application averaged ~50% slower for Combat Gauze (M = 41 seconds, 95%CI: 22-32 seconds) than for XSTAT (M = 27 seconds, 95%CI: 35-47 seconds). XSTAT application was faster than Combat Gauze for each wound location and size. The 10 cm wounds took ~10 seconds (36%) longer to close (M = 27 seconds, 95%CI: 35-47 seconds) than the 5 cm wounds (M = 27 seconds, 95%CI: 35-47 seconds). Blood loss was similar for Combat Gauze (M = 51 mL, 95%CI: 25-76 mL) and XSTAT (M = 60 mL, 95%CI: 30-90 mL). Blood loss was roughly twice as great for 10 cm wounds (M = 73 mL, 95%CI: 47-100 mL) than for 5 cm wounds (M = 38 mL, 95%CI: 18-57 mL). This pilot study supports the feasibility of a novel model for testing the iTClamp in conjunction with hemostatic packing towards controlling junctional hemorrhage.