INTEGRA® Dermal Regeneration Template is a two-layer skin regeneration system. The outer layer is made of a thin silicone film that acts as your skin's epidermis. It protects the wound from infection and controls both heat and moisture loss. The inner layer is constructed of a complex matrix of cross-linked fibers. This porous material acts as a scaffold for regenerating dermal skin cells, which enables the re-growth of a functional dermal layer of skin. Once dermal skin has regenerated, the silicone outer layer is removed and replaced with a thin epidermal skin graft. This completes the procedure and leaves you with flexible, growing skin.

In 1996, the US Food and Drug Administration (FDA) approved the use of INTEGRA® Dermal Regeneration Template for the treatment of life threatening burn injuries.

In 2002, the FDA approved the use of INTEGRA Template to include the reconstruction of scar contractures.

INTEGRA® Dermal Regeneration Template is indicated for the post-excisional treatment of life threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient.

INTEGRA® Dermal Regeneration Template is indicated for the repair of scar contractures when other therapies have failed, or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient.

When INTEGRA Template is placed on a wound where burned or scarred skin has been removed, INTEGRA provides the needed framework for the blood vessels and dermal skin cells to re-grow into a new skin layer. The silicone outer layer temporarily closes the wound to ward off infection and control fluid and heat loss.

As skin cells migrate into the matrix the collagen is slowly absorbed into the body and replaced with protein that is naturally produced by the skin. In approximately 14 to 21 days, new dermal skin is produced and the silicone layer can be removed. A thin skin graft of the person's epidermis is applied to the wound area to complete the procedure.

In total, the two surgical procedures are typically completed within 30 days. A person is left with flexible growing skin and minimal damage at the skin graft donor sites.

INTEGRA® Dermal Regeneration Template is manufactured and distributed by Integra LifeSciences Corporation of Plainsboro, New Jersey.

Yes, the product must be stored flat under refrigeration at 35 degrees - 46 degrees F (2-8 degrees C).
It must be protected from freezing.

INTEGRA® Dermal Regeneration Template is sold in sheets - 4 inch x 5 inch (10 cm x 12.5 cm), 4 inch x 10 inch (10 cm x 25 cm) and 8 inch by 10 inch (20 cm x 25 cm).

In the United States, it is offered as a 1 pack and a 5 pack. Outside the United States, it is only sold 1 per box. Each sheet is packaged in a foil pouch containing approximately 250 mL of 70% isopropyl alcohol. Each sterile foil pouch is packaged in a sealed outer chevron-style pouch.

INTEGRA® Dermal Regeneration Template can be meshed at 1:1 ratio with a "non-crushing" mesher (e.g. Brennen®) before the application, but must not be expanded. Meshing may improve the ability of INTEGRA® Dermal Regeneration Template to conform to irregular surfaces and may improve take on exudating wounds.

The product expiration date is 2 years. Lot number and expiration date information are included on the packaging.

All raw materials used in the manufacture of INTEGRA® Dermal Regeneration Template, including packaging and accessories, are not formulated with and do not contain any natural rubber latex or
dry natural rubber in accordance with US FDA Regulations (21 CFR Section 801.437).

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