Dermagraft is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold.

No. You will see new packaging design, but otherwise Dermagraft will remain the same high quality product it has always been.

Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients who have adequate blood supply to the involved foot.

Dermagraft is manufactured from human fibroblast cells derived from newborn foreskin tissue. 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 to create a three-dimensional human dermal substitute containing metabolically active living cells.

The safety of Dermagraft is assured through extensive testing. The proprietary freezing process (cryopreservation) allows for storage of the product while safety testing is conducted, to assure the product passes extensive safety requirements before shipment.

In a randomized controlled clinical trial, Dermagraft healed more chronic* ulcers and healed them faster than conventional therapy alone.

Dermagraft is supplied frozen in a clear bag containing one piece of approximately 2” x 3” (5 cm x 7.5 cm) for a single-use application.

When implanted into an adequately prepared diabetic foot ulcer, Dermagraft assists in the restoration of the dermal bed allowing the patient’s wound to heal (re-epithelialize).

More than 1,000 patients have been treated with Dermagraft in studies of various indications, including burns, venous ulcers, pressure ulcers, and diabetic ulcers. Dermagraft has been commercially available in many countries for more than 5 years. Since its approval in 2001, Dermagraft has been used on more than 15,000 patients with diabetic foot ulcers.

Because Dermagraft is stored at -75ºC ± -10ºC, it must first be thawed, rinsed, and then cut to fit exactly into the wound bed. The wound is thoroughly cleaned (debrided) and then Dermagraft is implanted. The wound is then protected with dressings and pressure-relieving footwear to help the healing process. This procedure is performed approximately weekly, usually in an outpatient office setting, until the ulcer is healed.