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.
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
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.
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
CELLULAR INVASION and CAPILLARY GROWTH
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
The silicone layer is removed.
The collagen template biodegrades and is absorbed
into the body.
Epidermal cells migrate
from the wound edges to complete wound closure.
Epidermal coverage over the wound yields a permanant
and lasting wound closure.