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To Develop and Demonstrate an Advanced Combat Wound Care Technology that Prevents Sepsis from Infected Traumatized Tissue

Description:

TECHNOLOGY AREA(S): Bio Medical

OBJECTIVE: To develop and demonstrate a technology that prevents infected and traumatized combat wounds on service members from becoming septic during extended tactical operations in austere environments. The technology shall be in an easy-to-use format, require minimal instrumentation, light weight, and compatible with care under fire (CUF). The method should enable deep tissue penetration of anti-microbial agents, analgesics, hemostatic agents, and pH stabilizers or oxygenating agents in the wound bed at minimum. The technology could be based on but not limited to a gel matrix, a fiber or polymer, a dissolvable gauze, spray and stay chemistry, nano-material, any wave or magnet based technology, or any combination thereof. All novel transformative technologies and ideas not identified here are welcomed.The end goal is to formulate a matrix technology that prevents infection and subsequent sepsis, preserves tissue viability, and promotes healing/regeneration of traumatic wounds in austere environments.

DESCRIPTION: Urban dense terrain and multi-domain operations of the future are expected to generate complex wounds that will require advanced prolonged field care and stabilization when tactical evacuations to robust rear element medical care infrastructures are delayed. Penetrating combat wounds can be accompanied by foreign body inoculum (metal fragments, rocks, dirt), large zones of bone and soft tissue disruption, nerve damage and localized ischemia (tourniquet/edema), as well as severe hemorrhage with resuscitation (often severe, >10U of 1:1:1 – pRBCs, plasma, and platelets that will systemically disturb overall physiology [immune system dysfunction, some degree of traumatic brain injury (TBI)]).Wound infections will be common in the multi-domain battle space and during prolonged field care; these infections could progress to sepsis. According to the Tactical Combat Casualty Care (TCCC) guidelines, the initial response to battlefield trauma is to stop major hemorrhage with pressure, tourniquet and wound packing with hemostatic agents along with broad spectrum battlefield antibiotics.The hemorrhage resuscitation, blast and use of tourniquets significantly reduce the efficacy of antibiotics in combat wound infections and topical treatments are urgently needed. Packing combat wounds with hemostatic agents with evaporative or tissue sealant properties in granular form or impregnated gauze appear to be effective topical treatments to control hemorrhage from these wounds (2,3). However, these approaches are not without their limitations in field applications to include incompatibility with brisk bleeding or coagulopathic patients (4,5) and their unsuitability for long term care (>4 - 5 h). While this paradigm was successful in recent operations where medical evacuation to a higher echelon of care was possible within hours of traumatic injury, the conceivable shift in the future battle space requires serious considerations to this evacuation strategy. As a result, the need for aggressive battlefield trauma care technologies that combine good medicine (i.e. better risk-to-benefit ratio)with host-physiology-augmenting innovations are paramount to controlling life threatening external hemorrhage and sepsis for complex battle wounded service members in austere environments that are removed from access to advanced medical care.The ultimate goal of the technology in this request is to augment current technologies available in the market in the form of gauze, gels, polymers, or powder that combine hemostatic agents with antimicrobial agents or analgesics alone. Commercialization of a technology that addresses the multidimensional problems of traumatized tissue biology will accelerate the next generation of innovations that combine tissue regeneration, pain management, and immune modulations to prevent sepsis and hemorrhage while expediting wound recovery. The aim of this SBIR/STTR is to develop a universal combat matrix of choice that may deliver multiple components such as but not limited to anti-microbial agents, analgesics, regenerative agents, immune modulators, hemostatic agents, oxygenating agents, and pH stabilizers deep into infected traumatize tissues to prevent sepsis. When proposing a technology, it is paramount, but not limited to, to consider the factors below:1) The starting technology plans to have or already has FDA or equivalent clearance for one or more indications 2) The anti-microbial of choice shall cover a wide array of infectious organisms 3) The analgesic of choice can be, but not limited to, non-opioid agents 4) The regenerative and immune modulators of choice can be, but not limited to,proteins, peptides, hormones, small molecules 5) The matrix should stabilize pH and endotherm conditions within the wound bed 6) The composition may include, but not limited to, hemostatic agents, metal ions, lantibiotics, natural products, bacteriophages, antibodies, polymers, nano-fibers 7) Controlled release of agents as a feature (optional) 8) If a wave or magnet based instrument is to accompany a given technology, simplicity of operation and weight will be considered 9) Effortless applications, ability to withstand high-winds, water, hot and cold temperatures and minimal storage conditions will be factored in the nomination process

PHASE I: Given the short duration of Phase I and the high order of technology integration required, phase I should focus on system design, compatible composition selection, and development of proof-of-concept prototypes that address the majority of the requirements of interest. Prototypes may combine “classes” of agents into different “sets” of matrices or formulations with sequential application to reflect the different stages and priorities of wound healing. At the end of this phase, working prototypes should demonstrate feasibility and proof-of-concept using in vitro systems for components of proposed technology and establish “release profile”.This phase should identify a pre-clinical animal model of infection, such as, but not limited to, punctured or open soft tissue wounds against a gold standard treatment for Phase II. Proposals may include different formulations for different phases of infection development and healing. Evaluation must include data for the first 24, 48 and 72 hours at a minimum, if not longer.

PHASE II: During this phase, the integrated system should be refined to enhance proof-of-concept into a product. Further optimization of technology for deep penetration of technology components into traumatized wound bed should be demonstrated during this phase. Qualitative and quantitative outcomes of product with regards to wound healing rate, regenerative properties, prevention of infection, pain control, hemorrhage control, and decolonization by invading organisms must be demonstrated as specific performance characteristics of the product compared to commercially available product. This testing should be controlled, rigorous, and under GLP conditions. Testing and evaluation of the prototype to demonstrate operational effectiveness in simulated environments (i.e. extreme heat, cold, wet environment) should be demonstrated. Here, the selected contractor may coordinate with WRAIR to set up testing sites and models. Stability of product in an austere environment should be evaluated to include extreme conditions. This phase should also demonstrate evidence of commercial viability of the product. Accompanying application instructions, simplified procedures and training materials should be drafted in a multimedia format for use and integration of the product into market. The offeror shall define and document the regulatory strategy and provide a clear plan on how FDA clearance will be obtained at the end of this phase. Offeror should also consider a pre-pre-submission communication with the FDA.

PHASE III: This phase should encompass both large animal models and randomized clinical trials that would require formal IRB approval as well as shelf-life optimization of at least 2 years in austere environments. The ultimate goal of this phase is to develop and demonstrate a technology enabling the prevention of sepsis in wounded service members from infected traumatic combat wounds and control of hemorrhage under prolonged field care with proper regulatory (FDA) clearance for human use. This effort should seamlessly be integrated into the TCCC paradigm of initial response to trauma. Once developed and demonstrated, the technology can be used both commercially in civilian or military settings to save lives. The selected contractor shall make this product available to potential military and civilian users. The contractor should coordinate with WRAIR/NMRC to establish a National Stock Number (NSN) as the first step towards the potential inclusion into appropriate "Sets, Kits and Outfits" that are used by deployed medical forces in the Defense Acquisition System.

KEYWORDS: wound infections, sepsis, prolonged field care, combat wound care, multi-domain operation, urban dense area warfare

References:

Kelly JF, Ritenour AE, McLaughlin DF, et al. Injury severity and causes of death from OperationIraqi Freedom and Operation Enduring Freedom: 2003–2004 versus 2006. J Trauma. 2008; 64.; Arnaud F, Parreno-Sadalan D, Tomori T, et al. Comparison of 10 hemostatic dressings in a groin transection model in swine. J Trauma. 2009; 67.; Kheirabadi BS, Bijan S, Scherer MR, et al. Determination of efficacy of new hemostatic dressings in a model of extremity arterial hemorrhage in swine. J Trauma. 2009; 67:450–59.; Kheirabadi BS, Mace JE, Terrazas IB, et al. Clot-inducing mineral versus plasma protein dressing for topical treatment of external bleeding in the presence of coagulopathy. J Trauma. 2010; 69:1062–72.; Kheirabadi BS, Bijan S, Mace JE, et al. Safety evaluation of new hemostatic agents, smectite granules, and kaolin-coated gauze in a vascular injury wound model in swine. J Trauma. 2010; 68:269–78.; Rozen, P.a.D., I., Wound Ballistic and Tissue Damage, in Armed Conflict Injuries to the Extremities, A.a.S. Lerner, M., Editor. 2011, Springer Heidelberg Dordrecht. p. 21-33.; Hospenthal, D.R. and C.K. Murray, Preface: Guidelines for the prevention of infections associated with combat-related injuries: 2011 update. J Trauma, 2011. 71(2 Suppl 2): p. S197-201.; Hospenthal, D.R., et al., Guidelines for the prevention of infections associated with combat-related injuries: 2011 update: endorsed by the Infectious Diseases Society of America and the Surgical Infection Society. J Trauma, 2011. 71(2 Suppl 2): p. S210-34.; Sheppard, F.R., et al., The majority of US combat casualty soft-tissue wounds are not infected or colonized upon arrival or during treatment at a continental US military medical facility. Am J Surg, 2010. 200(4): p. 489-95.

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