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Tissue Engineered Wound Matrix Products
(continued)
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INTEGRA®
(Collagen-Glycosaminoglycan Matrix) [Integrated Life
Sciences]
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Description:
Integra®
is an acellular, biodegradable
collagen-glycosaminoglycan (CG) copolymer matrix
coated with a thin polysiloxane (silicone) elastomer.
Bovine type I collagen and
chondroitin-6-sulfate, one of the major
glycosaminoglycans, are co-precipitated, freeze-dried
and cross-linked. The collagen structure is manufactured. The pore size has been determined to maximize in-growth
of cells, and the degree of cross-linking as well as
GAG composition, is designed to control the rate of
matrix degradation.
This extracellular matrix analog
incorporates in about 2-3 weeks forming a neodermis
with new
vasculature. In animal studies, when this matrix was
seeded with auto-genous keratinocytes, collagen fiber
orientation and elastin fiber structure resembled
native dermis. The
response in humans as to dermal quality remains to be
determined.
The
Integra acellular cryo-preserved allodermis is
clinically used in conjunction with ultra thin (0.003
to 0.006 inch) meshed split-thickness autografts in
large burn wounds.
Several clinical studies have been performed,
reporting an equivalent fourteen day graft take rate
of this dermal matrix with traditional split-thickness
autografting. Follow-up to six months demonstrated
equivalent clinical assessments to Alloderm – ultra
thin autograft combination.
This product is currently not being used in
chronic wounds.
Indications:
Closure
of full thickness burns I the primary indication.
Recently Integra has also been used to
reconstruct complex full thickness non-burn wounds
and scar contractures.
Healing Environment: A moist healing environment is present
below the INTEGRA.
Application: INTEGRA
is applied directly onto an excised wound once
hemostasis has been obtained.
The dermis side is applied onto the wound
surface.
The sclastic membrane is then covered with a
moist secondary dressing and the wound is
immobilized.
How
Stored:
Each sheet is packaged in a foil pouch containing 250ml of 70% isopropyl
alcohol.
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DERMAGRAFT®
(Fibroblast
Derived Dermal Substitute) [Smith
& Nephew]
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Description:
DERMAGRAFT®
is
a cryo-preserved human fibroblast derived dermal
substitute. It
is compared of fibroblasts, extracellular matrix
(produced by the neonatal foreskin), cultured
fibroblasts. The
cultured fibroblasts are seeded onto a bio-absorbable
polyglactin mesh scaffold.
The fibroblasts proliferate to fill the
interstices of this scaffold.
Human dermal collagen, matrix proteins, growth
factors and cytokines, are produced. A human dermal substitute is produced containing
metabolically active, living cells.
It is assumed that these cells produce
biologically active proteins such as growth factors.
The product is used primarily for clean
diabetic ulcers.
It is typically used for small chronic wounds.
There is no indication for use in large
traumatic wounds or partial thickness burns.
Indications:
Clean
diabetic ulcers, other chronic wounds.
How Supplied:
Dermagraft
must be frozen at -70° C and implanted within 30
minutes of thawing.
Size is 2 inches by 3 inches.
Healing Environment: Moist
wound healing.
Application:
Dermagraft
must first be thawed then immediately applied to a
clean uninfected wound and moist wound healing,
using moist dressings, must be provided to avoid desiccation.
The plastic is peeled from both ends of the
Dermagraft.
A non-adherent dressing is then applied,
providing a moist wound environment .
The first dressing is changed at 72 hours.
Dermagraft is reapplied as it incorporates.
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ORCEL®
(Living Skin Equivalent) [Ortec
International]
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Description:
OrCel®
is comprised of a bilayer reconstituted collagen
sponge that contains cultured living human dermal and
epidermal skin cells.
Allogeneic human cells from neonatal foreskin
are seeded into the collagen sponge.
It is stated that these cells release growth
factors and other active dermal proteins which then
stimulate healing.
The epidermal and dermal fibroblasts are
cultured in two separate layers on a type I bovine
collagen sponge.
The collagen lattice is manufactured.
An
open sponge structure permits dermal cells to migrate
into and throughout the sponge and to deposit human
collagen and glycosaminoglycans (human skin
“biomatrix”).
The open pores allow the patient’s wound bed
fibroblasts to regenerate the dermis and endothelial
cells to revascularize the tissue to migrate in and
rebuild the tissue.
The
collagen sponge is porous.
It serves to absorb the wound fluid in an
exudating wound.
Additionally, the porosity allows the exudating
wound fluid passage into the outer dressing.
This prevents the OrCel®
from lifting off the wound bed.
Indications:
FDA
approval is for epidermolysis bullosa, and skin
graft donor sites.
Studies are also being pursued in venous
ulcers and diabetic foot ulcers.
OrCel has been reported to decrease the donor
site healing time by one third compared to the use
of grease gauze.
Healing Environment: Moist
wound healing.
Application:
OrCel
is applied once and covered with a secondary
dressing.
How
Stored:
Cryopreserved
in frozen state.
Shelf life, as yet undetermined.
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EZ
DERM®
(Matrix Dressing) [Brennan]
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Description:
EZ Derm is a porcine derived xenografts which has been
chemically modified to provide durability and storage.
The dermal elements from the original pig
dermis are likely all deactivated in the chemical
process, unlike the frozen pig dermis which is still
available. It
appears that the product is a collagen scaffold. There is no data to indicate that this dressing stimulates
healing. The product is not
incorporated and must be removed.
Indications:
Recommended
for use in partial thickness wounds, donor sites,
ulcers and meshed autografts.
Healing Environment:
Moist wound healing.
How Applied:
Apply
out of the package to a viable wound bed, followed
by a secondary dressing.
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