A.M. Jorgensen
SiOxMed, LLC,
United States
Keywords: Medical Devices, Hemostasis, Wound Matrix, Noncompressible Wounds, Junctional Wounds, High Pressure Wounds
Summary:
Introduction: Uncontrolled hemorrhage is a leading cause of death in combat and civilian trauma cases. Current advanced hemostatic dressings exhibit notable mortality rates and necessitate urgent surgical intervention for permanent vessel or organ repair. Addressing this, SiOxMed introduces a novel material, the universal combat trauma dressing (UCTD), designed to control lethal hemorrhage and support injured areas en route to surgical care. This study evaluates the multi-modality hemostatic capability of the UCTD in porcine models featuring femoral artery injury, abdominal aortic injury, and grade IV liver injury. Methods: Anesthetized and supine subjects underwent femoral artery puncture, abdominal aorta puncture, or grade IV liver injury, with treatments of UCM or QuikClot. Assessed parameters included time to hemostasis, total blood loss, treatment item mass, and survival percentage. Post-euthanasia, histological samples were collected for injury site evaluation. Femoral artery injuries, created by a 6mm punch biopsy with a 30-second bleeding period, exhibited reduced time to hemostasis and blood loss with UCM treatment. Abdominal aorta punctures, using a 4mm punch biopsy, showed improved survival (100% vs. 33%) and 20 times less material weight with UCM. Grade IV liver injuries, induced by "X" shaped wedges, were rapidly hemostatic with UCM, and all subjects survived for two days, demonstrating a fibrin bridge and regenerative healing in histological analysis. Results: UCM exhibited hemostatic properties, effectively stopping junctional, high-pressure aortic, and non-compressible liver hemorrhage. The material is easy to apply and achieves rapid, stable, multi-day hemostasis. Histological images depict a thick fibrin bridge and evidence of regenerative healing. Conclusions: These findings warrant further studies to determine the need for surgical intervention in these specific injuries. UCM's light weight and efficacy make it an ideal hemostatic agent for military personnel, offering a universal treatment capacity and serving as a multi-day hemostatic bridge to definitive care in far-forward multi-domain battlefields.