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Autograft-Sparing Products for Definitive Care of Burn Injuries

The Biomedical Advanced Research and Development Authority (BARDA) is seeking to fund late-stage development and procurement of autograft-sparing products that can enhance the capacity to provide definitive care for thermal burn injuries.

In mass casualty incidents, especially one resulting from the detonation of an improvised nuclear device (IND), 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. Some victims are likely to suffer burns and trauma, along with radiation exposure as well.

Field Care and Definitive Care

Mitigating burn injuries in a mass casualty incident 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.

Burn Wound Closure

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 quality of outcome.

Skin substitutes will not be considered as a possible solution under this category of products. 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 treatment of deep partial and/or full thickness skin burn injuries.

Products are to be procured in sufficient quantities at the discretion of the USG to enable an effective emergency response either upon FDA approval or under other authorities available under Project BioShield, as appropriate.

Further details are available via Solicitation Number: 15-100-SOL-00019. The response deadline July 27, 2015.

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