FDA-Approved Autograft Sparing Device for National Preparedness

FDA-Approved Autograft Sparing Device for National Preparedness. Capabilities for building national preparedness against large burn mass casualty incidences (BMCI) as they could quickly overwhelm the US healthcare infrastructure. Treatment and care for burn injuries in adults and childern is labor intensive and influenced by the unique properties of each case with complicating factors including patient age and health as well as burn area and depth.

The challenges of providing definitive burn care are heightened when delivering treatment after a mass casualty event in a resource strained environment. 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 labor-intensive, requires training, is time consuming and invokes additional risk to the patient due to the operative procedures at multiple sites. Discussions with the professional burn community and market research data indicates that products that reduce the amounts of autograft needed to provide wound closure (autograft-sparing) can provide an advantage for rapid and effective care of severe burn injuries.

Such products also have the potential to reduce the morbidity of the donor sites. Such products should be compatible with current procedures to allow easy integration so they could be also used during a mass casualty scenario involving significantly high numbers of burn patients. Additionally, such products that have additional indications for full thickness skin defects due to traumatic injury would be advantageous to address other injuries which result in a mass casualty incident (MCI).