A Portable Wound Hemostasis System Using a Hydrogel Polymeric Foam

描述（由申请人提供）：严重的高能量和穿透性创伤可导致急性休克和死亡。在手术护理之前，现场急救对于获得最佳结果至关重要，因为不受控制的出血可能导致死亡;污染可能导致感染;四肢伤口的骨骼稳定性不足可能导致持续的软组织损伤。目前的腹部伤口或肢体损伤的紧急稳定方法是为短期应用而设计的，同时受害者被分类和运送进行进一步护理。除了血流动力学稳定的方案外，现场腹部手术的原则 肢体创伤护理包括出血控制、伤口敷料、急性畸形（如果是肢体）的复位和外部夹板固定。然而，止血带的应用应限于缺血性坏死发生前2小时，除非由护理人员手动进行，否则直接加压是困难的，这在某些情况下可能是不可能的，例如军事行动，或者当伤亡人数超过紧急响应人员的人数时。对于开放性肢体非动脉伤口，减少受伤肢体畸形需要对齐、夹板和加压敷料。夹板可以在手术外固定或内固定之前使用几个小时来稳定肢体，但稳定性可能是次优的，并且没有外部夹板固定的标准，这可能导致不一致的稳定性，这可能增加后续并发症的风险，包括筋膜室综合征，败血症，以及软组织和血管损伤的进展，伴随全身炎症介质的持续释放和疼痛。如果要及时进行手术护理和清创，最初可以忽略严重的伤口污染，但尚不清楚这样做是否会增加延迟伤口感染的风险。此外，在受伤现场对急性开放性伤口应用止血剂、止痛剂或防腐剂也没有标准。在某些情况下，如在军事伤害中持续的创伤，在农村或荒野环境中，或在任何其他救援延迟的环境中，紧急手术护理可能在创伤事件发生后数小时或数天内不可用。为了解决这些情况，我们假设可逆的水凝胶基泡沫的发展作为一个便携式系统的腹部伤口的紧急止血，局部镇痛，消毒和补充软组织稳定将提供更好和更快的访问初始是在现场的伤害比目前的标准。为此，我们的目标是I）设计和优化基于水凝胶的试剂（及其溶剂）作为用于部署的主要载体，其将渗透通过闭合的腹部伤口并在其中膨胀;建立针对动脉压的止血;并且还补充有镇痛剂和防腐剂;以及II）评估便携式雾化试剂在体内猪损伤模型中的止血能力的功效。 公共卫生相关性：我们的目标是开发基于水凝胶的、雾化的和可逆的泡沫，作为用于紧急腹部和四肢伤口护理的便携式系统，其将提供比目前标准更好的关键初始护理。

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.