Objectives and Rationale: The objective of this work is to refine and demonstrate efficacy of a new hemostatic (blood clotting) wound care product for military use on the battlefield, for civilian traumatic injuries, and during surgical procedures. The product is a foam made of chitosan and starch, which are both used separately in other commercial products to stop both bleeding from injuries and during surgeries. This proposal will allow for development of the most effective composition of the foam and for demonstrating the effectiveness of the material by creating wounds in a live pig model. The artery that supplies blood to the leg will be injured, resulting in significant bleeding. This pig model has been used to test the efficacy of similar products. There are still a significant number of potentially preventable deaths that occur in the field secondary to blood loss, which is the motivation for this project. Comparison will be made to another product, Combat Gauze, which is currently used in the field. The goal of this comparison will be to show superiority of the novel foam to Combat Gauze in stopping bleeding and improving survival in the pig model. Applicability: There is a significant clinical need for materials that can aid in the cessation of bleeding and promote rapid clotting for a variety of internal and surface wounds or during surgical procedures especially in combat casualty care. The applicability of this research will be to improve medical care in the field and to ultimately help prevent deaths due to blood loss. Once efficacy has been shown in the pig model, weather and fluid-resistant packaging would be developed, and ease of use by pre-hospital providers would need to be assessed. In the future, the foam can be trialed in human patients in the pre-hospital and combat setting. Focus Area: The Focus Area that will be addressed by this project is Focus Area 3: 'Develop enhanced treatment of injuries during prolonged field care (PFC) and prolonged damage control resuscitation (pDCR).' In combat, potentially preventable deaths due to hemorrhage can be mitigated by an improved product than those currently available for use. Clinical Applications, Benefits, and Risks: Clinical applications include use in combat to stop bleeding from battlefield wounds, as well as use in the pre-hospital environment by paramedics, in the emergency department, and operating room. There is a potential to incorporate this foam into bandages with an adhesive cover for use as an over-the-counter product. Its applicability in the treatment of traumatic hemorrhage rests not only in its ability to expand to stop bleeding by compression, but also with the unique ability to do so within irregular and deep wounds. As such, the product will have diverse utility in the treatment of external hemorrhage ranging from lacerations to penetrating wounds. Because it is biodegradable and bioabsorbable, the foam will also possess great opportunity for use in internal bleeding (i.e., bleeding due to a liver injury). The product does not need to be removed because the body can break it down over time, and it will not cause any allergic reaction by remaining in place.
|Effective start/end date||6/1/18 → 6/1/18|
- U.S. Army: $1,436,358.00
- U.S. Army: $1,436,358.00