Wounds

Clinical Trial – Limb Salvage Through Tissue Engineering: A Novel Treatment Modality Using Dehydrated Human Amnion/Chorion Membrane

Extremity wounds with exposed critical structures, including bone and tendon are a major
burden on the American healthcare system with limited treatment options. Free Flap
reconstructions of lower extremity wounds have an increased failure rate in comparison to
elective free flap procedures.These procedures are long and are associated with a high cost
of care, prolonged hospital stays, and are limited by the need for surgical specialist
availability and patient vessels suitable for anastomoses. This study will use a new
treatment modality which is a commercially ready human amniotic membrane allograft (EpiFix)
to promote a granulation tissue wound base that will be suitable for skin grafting, thus
forgoing the need for a flap-based for reconstruction. The study goals are to reduce the
overall cost of providing definitive treatment by decreasing operative time, length of
hospital stay, decrease the need for intensive nursing care and rehabilitation. This study
will aim to provide a treatment option that is readily accessible to all patients with these
complex wounds in any healthcare setting across the country.

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