How is artificial skin used in treating patients?
Integra Dermal Regeneration Template (DRT) was first approved by the FDA for life-threatening third degree burns, and the medical community appreciates its role in regenerating the dermis without the need for a full-thickness skin graft. The product also has FDA approval for reconstructive surgery, where a patient has suffered severe loss of tissue. Another big application area is treating non-healing chronic wounds, such as leg and foot ulcers. Integra DRT, when placed on an open wound, regenerates dermis in about three weeks.
Describe the material makeup of Integra DRT.
The active component is a bovine collagen matrix—about 100 microns in porosity. This collagen matrix layer is bonded to an outer layer of silicone, which peels off as the patient recovers. The collagen matrix is processed to maintain a sufficient number of biochemical cues to persuade a fibroblast entering the matrix that it is encountering healthy dermis. The cells respond by dividing and laying down basal lamina. Over three or four months, you are left with pure human collagen in the dermal matrix and there is nothing left of the implanted material.
What is involved in the manufacturing process?
The collagen matrix is manufactured from collagen fibers derived from highly processed bovine Achilles tendon, using a similar process used to manufacture paper. Once the collagen matrix has been produced, we coat one surface with silicone rubber to allow easier handling of the delicate matrix and also to provide a vapor/fluid barrier when the system is applied to the patient. The finished product, about 2 mm thick and available in sheets as large as 8×10 inches, is a sterile material manufactured in a Class 10,000 clean room.
When is artificial skin considered to be the optimum treatment solution?
In cases where third degree burns cover 50 percent or more of the body, artificial skin may be the only solution. There simply is not enough healthy skin for autografts. If a patient is sick or elderly, even burns covering much smaller areas can be very serious. By using artificial skin, you do not have to cause the patient the additional trauma of taking a skin graft and creating another wound.
What comments do you get from the medical community on the product?
In many cases, doctors say they could not save a person's life without Integra. But there's also a great impact on quality of life for the patient. The regenerated skin does not contract, so people have full range of motion. Others regain mobility in their limbs after reconstructive surgery, when Integra is applied to replace scar tissue from past burns. Transformations can be quite emotional. A child in France suffered third-degree burns over 100 percent of her face. In a year, she regained much of her original appearance due to the material.