Product Description and Benefits
  Proposed Indications for Use
  Product Makeup

How INTEGRA® Dermal Regeneration Template Works
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When INTEGRA® Dermal Regeneration Template is placed on a surgically debrided or excised wound, it provides the needed framework for the blood vessels and dermal skin cells to remodel the damaged site.

As skin cells migrate into the matrix, the collagen is slowly absorbed and replaced with collagen produced from the person's own cells. In approximately 14 to 21 days, the scaffold is eventually remodeled as the patient's cells rebuild the damaged site and the silicone layer is removed. Complete wound closure occurs as epidermal cells migrate from the wound edges.

Clinical Sequence

DAY 0:

All chronic wound patients must have accurate diagnosis and treatment of underlying disease and risks. There must be thorough pre-operative control of inflammation, ulceration, debris and bioburden, and edema (as best as the disease and available treatments permit).

DAY 1:

Prepare wound bed using standard methods allowable in this clinical trial protocol to ensure wound is free of debris and necrotic tissue. Regardless of how well the wound has been prepared and how healthy it looks, INTEGRA® Dermal Regeneration Template must not be placed on an existing wound surface. The entire existing wound must be completely excised or surgically debrided to ensure the wound bed and edges contain viable tissue.

DAY 1:

INTEGRA® Dermal Regeneration Template is applied to the excised wound bed. Fluids invade the matrix within minutes of application, adhering it to the wound. The Integra must conform to and contact the wound surface. Tension within the material will shear the matrix from the silicone, so the material must not be stretched. It can be affixed with sutures, staples, or any suitable alternative.

DAY 7-14:

Dermal cells begin migrating into the matrix and establish a new vascular network. The scaffold is eventually remodeled as the patient's cells rebuild the damaged site.

DAY 21+:

The silicone layer is removed. The collagen template biodegrades and is absorbed into the body.

DAY 21-56+:

Epidermal cells migrate from the wound edges to complete wound closure.

Epidermal coverage over the wound yields a permanant and lasting wound closure.


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