Chronic, stalled wound biology: Adding Dermagraft helps to reestablish the dermal bed5

  • Chronic diabetic foot ulcers (DFUs) demonstrate impaired healing that results from multiple pathological factors (eg, vascular insufficiency, altered cellular activity, and a dysfunctional extracellular matrix), leading to a deficient wound bed, which often fails to respond to conventional therapy alone5-7
  • Dermagraft helps to restore the compromised DFU dermal bed to facilitate healing by providing a substrate over which the patient’s own epithelial cells can migrate to close the wound5
    • Composed of human fibroblasts, an extracellular matrix, and a  bioabsorbable polyglactin mesh scaffold1
    • Cryopreserved, 3-dimensional, human dermal substitute1
    • Allows for serial applications without the need for removal of the product from the wound1

The persistence of Dermagraft in the wound and the safety of this device in patients with diabetic foot ulcers beyond 6 months has not been evaluated. Testing has not revealed a tumorigenic potential for cells contained in the device. However, the long-term response to these cells is unknown.

Dermagraft is a 3-dimensional human dermal substitute1

Dermagraft-is-a-3-dimensional-human-dermal-substitute

References: 1. DERMAGRAFT Directions for Use. Organogenesis. 2013. 2. Marston WA, et al. Diabetes Care. 2003;26(6):1701-1705. 3. Data on file. Shire Regenerative Medicine. 2013. 4. US Food and Drug Administration. Medical Devices. Premarket Approval. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm. Accessed February 6, 2013. 5. Roberts C, et al. Can J Plast Surg. 2002;10(suppl A):6A-13A. 6. Loots MAM, et al. J Invest Dermatol. 1998;111(5):850-857. 7. Margolis DJ, et al. Diabetes Care.1999;22(5):692-695. 8. Brem H, et al. Plast Reconstr Surg. 2006;117(7 suppl):S193-S209. 9. Gentzkow GD, et al. Diabetes Care. 1996;19(4):350-354.