A Portable Wound Hemostasis System Using a Hydrogel Polymeric Foam

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DESCRIPTION (provided by applicant): Severe high energy and penetrating trauma can result in acute shock and death. Emergent care at the scene is essential for optimal outcome prior to surgical care, as uncontrolled bleeding can result in death; contamination can result in infection; and inadequate skeletal stabilization of extremity wounds can result in continued soft tissue injury. Current methods of emergent stabilization of an abdominal wound or a mangled extremity are designed for short-term application while the victim is triaged and transported for further care. In addition to protocols for hemodynamic stabilization, principles of field abdominal and extremity trauma care involve hemorrhage control, wound dressing, reduction of acute deformity (if an extremity), and external splinting for stabilization. However, tourniquet application should be limited to 2 hours before ischemic necrosis occurs, and direct pressure is difficult unless performed manually by a caregiver, which may not be possible in some scenarios such as military action, or when the number of casualties exceeds the number of emergency responders. Reduction of deformity in injured extremities requires alignment and splints and compression dressings for open extremity non-arterial wounds. Splints can be used for several hours to stabilize an extremity before surgical external or internal fixation is applie, but stability may be sub-optimal, and there are no standards for external splinting which may result in inconsistent stabilization that may increase the risk of subsequent complications, including compartment syndrome, sepsis, and progression of soft tissue and vascular injury with persistent release of systemic inflammatory mediators and pain. If surgical care and debridement is to be preformed promptly, heavy wound contamination can be initially neglected, but it is unclear if doing so facilitates the risk of delayed wound infection. Furthermore, there ae no standards for the application of hemostatic, analgesic or antiseptic agents to an acute open wound at the scene of injury. In some scenarios such as trauma sustained in military injuries, in rural or wilderness settings, or in any other setting with delayed rescue, emergent surgical care may not be available for hours or at times days after the traumatic event. To address these scenarios, we hypothesize that the development of reversible hydrogel-based foam as a portable system for emergent hemostasis of abdominal wounds, local analgesia, disinfection and supplemental soft tissue stabilization will provide better and faster accessibility to initial are at the scene of injury than present standards. To that end, we aim to I) Design and optimize a hydrogel-based agent (and its solvent) as the primary carrier for deployment that will permeate through and expand in a closed abdominal wound; establish hemostasis against arterial pressure; and also be supplemented with analgesic and antiseptic agents; and II) Evaluate the efficacy of the hemostatic capabilities of the portable aerosolized agent in an in- vivo swine model of injury. PUBLIC HEALTH RELEVANCE: Our objective is to develop hydrogel-based, aerosolized and reversible foam as a portable system for emergent abdominal and extremity wound care that will provide critical initial care significantly better than present standards.