1. Section Editor(s): Hess, Cathy Thomas BSN, RN, CWOCN

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The Food and Drug Administration (FDA) has approved Dermagraft for the treatment of chronic diabetic foot ulcers in conjunction with standard wound care. Dermagraft, manufactured by Advanced Tissue Sciences, Inc, La Jolla, CA, and distributed by Smith & Nephew, Largo, FL, is indicated for the treatment of full-thickness diabetic foot ulcers of longer than 6 weeks' duration that extend through the dermis but without tendon, muscle, joint capsule, or bone exposure.


Dermagraft is a cryopreserved, human fibroblast-derived dermal substitute composed of human fibroblasts, human extracellular matrix, and a bioabsorbable scaffold. During the manufacturing process, the human fibroblasts are seeded onto a bioabsorbable polyglactin mesh scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors, and cytokines, creating a 3-dimensional human dermal substitute containing metabolically active, living cells.


This is the first FDA approval for a tissue-engineered, living dermal substitute that is human-based, mass-produced, and cryopreserved. Dermagraft's 6-month shelf life allows a 14-day USP sterility test to be performed before any product is released.



Ortec International, Inc, New York, NY, has received Food and Drug Administration (FDA) approval for its bilayered cellular matrix, OrCel, for healing donor site wounds in patients with burns.


In an 82-patient controlled, pivotal trial, OrCel demonstrated that it accelerated the healing of donor site wounds when compared with a currently used standard-of-care therapy. The median healing time for the donor site wounds treated with OrCel was on average one-third shorter than control-treated wounds. In addition, treatment with OrCel resulted in statistically significant differences in scar outcomes when compared with the control therapy at weeks 12 and 24 following treatment.


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