- What is Dermagraft?
- What are the indications for Dermagraft?
- How is Dermagraft manufactured?
- How is Dermagraft supplied?
What is Dermagraft?
Dermagraft is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioresorbable scaffold.
What are the indications for Dermagraft?
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.
Contraindications:
- Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts
- Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution
How is Dermagraft manufactured?
Dermagraft is manufactured from human fibroblast cells derived from newborn foreskin tissue. During the manufacturing process, the human fibroblasts are seeded onto a bioresorbable 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. Dermagraft does not contain macrophages, lymphocytes, blood vessels, or hair follicles.
How is Dermagraft supplied?
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.