Injectable Reversible Chitosan Foam for Treatment of Noncompressible Hemorrhage
Abstract
This research aims to develop an injectable foam hemostat for treatment of non-compressible hemorrhage (intracavitary bleeding from soft tissues), which is the leading cause of death (~85%) for bleeding-related trauma (e.g., a shrapnel injury in the abdomen). The foam material is based on a naturally occurring biopolymer that is inherently antimicrobial and wound healing; a proprietary modification to this biopolymer allows it to clot blood rapidly and hold together effectively against high-pressure blood flow. The injectable foam will increase survival during long pre-hospital periods by staunching internal bleeding quickly. Furthermore, the foam can be removed from the site by a complementary technology based on a food additive, which is delivered as a cleaning solution by the trauma surgeon on the operating table. The foam is created in a mixing tip of a double barrel syringe containing the biopolymer gel on one side and a foaming solution on the other. Upon mixing, the foam expands into a closed cavity where the bleeding is occurring. The ultimate applicability of the project is to develop a syringe product containing an optimized modified chitosan for non-compressible bleeding control. Foam formulations will be tested for safety and efficacy against this type of bleed in animals with the objective of obtaining Food and Drug Administration approval at or near the completion of this project. The Fiscal Year 2016 Prolonged Field Care Research Award Focus Area addressed by this project is Focus Area 3: Develop enhanced treatment of injuries during prolonged field care (PFC) and prolonged damage control resuscitation (pDCR). The applicable sub-segment of Focus Area 3 is: Forward surgical techniques, knowledge products, and augmentative technology for surgical stabilization of life- and limb-threatening injuries. Specifically, this application aims to address the stated need to stabilize bleeding patients during PFC by using a novel injectable "reversible" biopolymer foam at the site of injury. The broader impact of this project falls in the arena of battlefield and trauma medicine. Foams are the future of acute wound treatment on the battlefield and in emergency medical services. Severe bleeding, especially internal bleeding, is not easily treated with a spatially contained product, such as a bandage. Furthermore, correct bandage placement on an acute wound requires a great deal of skill and experience. However, an injectable foam is very user friendly and allows potential for adequate self-application or application by an unskilled "buddy" for a wide range of hemorrhage types. Thus, we envision our chitosan foam as a necessary supply in the Soldier s backpack, the emergency room, and the home first-aid kit. This vision is a viable economic prospect because the material is low-cost, lightweight, and highly durable even in extreme ambient conditions. Additionally, the reversibility provided by the complementary system provides a streamlining tool for the trauma surgeon. Removal of hemostatic material and precise identification of the injury site are necessary tasks in the operating room, which are made much easier by this unique technological feature. Key risks of the project include (i) inadequate efficacy for extremely difficult-to-control internal bleeds and (ii) common safety issues for novel biomaterials, such as irritation, as a result of delivery of a large amount of biomaterial into a compromised body cavity. This project will benefit Soldiers on the front lines who are at risk of experiencing life-threatening bleeding. Of course, it will also benefit the medics who treat them; the material acts quickly without the need for lengthy compression. The resulting product could extend their lives after a non-compressible bleed so as to give them time to reach the operating room and receive treatment in a controlled environment. Benefits to the civilian population include use of this exact produ
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1810006
Entities
People
- Matthew Dowling
Organizations
- United States Army