A. Jorgensen, M. Loll, D. Hickerson, W. Rowe, W. Hickerson
SiOxMed,
United States
Keywords: medical devices, hemostasis, wound matrix, noncompressible wounds, junctional wounds, high pressure wounds
Summary:
Uncontrolled hemorrhage remains the leading cause of death for combat casualties and the second leading cause of death in civilian trauma patients. Thus, there is a critical need to test and validate new hemostatic dressings that control lethal hemorrhage while supporting the injured area enroute to surgical care. To address these challenges, SiOxMed has developed a novel hemostatic matrix (HM) that displays hemostatic and wound repair properties. This novel material (not yet assessed by the FDA) can be applied with little training, is light weight, and requires no special storage. In this study, we assess the multi-modality hemostatic capability of the matrix in porcine lethal hemorrhagic injury models, including: femoral artery injury (junctional wound), an abdominal aortic injury (high pressure wound), and grade IV liver injury (non-compressible wound). The subjects were anesthetized and stabilized in a supine position, and received one of three hemorrhagic injuries: femoral artery puncture, abdominal aorta puncture, or grade IV liver injury. The injuries were treated with either HM or a QuikClot® Combat Gauze (QC). The time to hemostasis, total blood loss, mass of treatment items used, and survival percentage were measured. Following euthanasia, histological samples were collected for assessment of the treated injury site. In the femoral artery injury, there was a reduction in time to hemostasis and total blood loss in the HM treated group compared with control. Histological analysis of the samples demonstrated that the HM treated wound formed hemostatic plugs of mixed composition with red blood cells, platelets, and fibrin, with a fibrin bridge formed across the inner surface of the injury. In the abdominal aorta injury, injuries treated with HM demonstrated improved achievement of hemostasis compared with control (100% vs. 33%), with two of three HM treated animals surviving to the 24hr study endpoint. Furthermore, the HM treated wounds used 20 times less material weight compared with control treated injuries (20g vs. 415g). Histological analysis of the treated injuries demonstrated that the HM treated wounds formed hemostatic plugs of mixed composition with red blood cells, platelets, and fibrin, with a fibrin bridge formed across the inner surface of the injury. In the grade IV liver injury, all three non-compressible liver injuries treated with HM were rapidly hemostatic and all three study animals survived to the 48hr study endpoint. Histological analysis again demonstrated a fibrin bridge that formed across the open wound. Vessels near the injury site remained patent, providing evidence that good vascular pressure was restored following injury hemostasis. In some samples, newly formed septa were visible on the edge of the transected liver lobules. These results demonstrate the hemostatic properties of HM to stop junctional, high pressure aortic, and non-compressible liver hemorrhage. The material is easy to apply, and achieves rapid, stable, multi-day hemostasis. Taken together, the universal treatment capacity, light weight, and ease of use make this an ideal technology for military personnel and first responders as a multi-hour to multi-day hemostatic bridge to definitive care.