The Biomedical Advanced Research and Development Authority (BARDA) is seeking to fund late-stage development and procurement of novel products to advance readiness to treat mass casualty burns.
In mass casualty incidents, especially one resulting from the detonation of an improvised nuclear device, thermal burn injuries are one of the significant public health consequences. Several types of burns may be expected due to the release of an immense amount of thermal energy and the resulting secondary fires.
Responding to mass casualty burn injuries requires a two-staged strategy, termed ‘Field Care’ and ‘Definitive Care’. Field Care occurs at the site of injury to provide initial treatment for burn wounds. Victims may also require treatment for trauma, including monitoring of their vital signs for airway, breathing, and circulation.
For victims of substantial burns, fluid replenishment is particularly important to prevent other complications. Consequently, during field care, the initial treatment goals focus on stabilizing patients by immediately addressing trauma and providing clean, anti-infective protective cover for burn injuries followed by fluid replenishment and pain medication.
Upon triage, patients are transferred to medical centers specialized for burn injuries where personnel and products become accessible to initiate long-term ‘Definitive Care’ in a more controlled environment.
Cell-based skin substitutes requiring a single surgical application (in lieu of autografting) would increase treatment capacity to provide definitive wound closure to burn injuries. The use of skin substitutes particularly during public health emergencies could potentially reduce the time, labor, and resource burdens associated with standard of care.
This would free up resources to enable treatment for more patients. Highly desirable skin substitutes are those which are fully resorbable, facilitate definitive wound closure of partial thickness and even full thickness burn wounds, and require no additional surgical procedures after placement on the excised burn wound.
A key potentially desirable attribute of cell-based skin substitutes may be to reduce or eliminate the need for autografting and thereby increase the efficiency of burn care by promoting faster burn wound healing and recovery.
Autografting is the current standard of care for long term treatment and recovery of deep partial and full thickness burn injuries. This involves removing healthy skin from an uninjured area of the patient’s body and affixing it on top of the burn wound.
The autografting procedure is laborintensive, requires training, is time consuming and invokes additional risk to the patient due to the operative procedures at multiple sites.
Deployment of non-surgical debridement products would increase the treatment capacity during public health emergencies by providing easier ways to remove necrotic burn tissue versus current surgical procedures.
This would reduce resource burdens associated with surgical procedures (materials, operating rooms, specialized medical personnel, etc.) and enable more patients to receive definitive closure for burn wounds within the clinically required time frames.
Candidate products are expected to reduce the amount of surgical excision procedures and may also demonstrate other desirable attributes, such as better resource utilization, reduction in burden on the surgical operating rooms, and aid prioritize delivery of burn care without compromise in the healing time for wound closure and quality of functional outcome.
Overall, such products would increase the ability of medical responders to provide definitive care for more patients during a public health emergency than the current standard of care. All candidate products are expected to be in late-stage development (in active clinical Phase II or beyond) with supporting data for a commercial indication for burn care and able to be accessed in sufficient quantities to enable an effective emergency response.
Autograft-sparing products are intended to provide definitive burn wound closure while requiring the use of less donor-tissue for autografting than the equivalent standard of care practice for treatment of deep partial and/or full thickness skin burn injuries.
Such products may also demonstrate other desirable outcomes when compared to the standard of care, such as but not limited to, lower donor site morbidity, reduction in healing time to achieve wound closure and improved functional and/or cosmetic quality of outcome.
BARDA is seeking to fund autograft-sparing products that can enhance the capacity to provide definitive care for thermal burn injuries. Skin substitutes will not be considered as a possible solution under this category of products.