| Frequently Asked Questions |
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If you would like immediate assistance with a question,
please contact one of our technical representatives
at 1-877-444-1122 or you may contact your local Plastic
and Reconstructive
Sales Specialist.
What is INTEGRA™ Bilayer Matrix Wound
Dressing?
What is INTEGRA™
Bilayer Matrix Wound Dressing?
INTEGRA™ Bilayer Matrix Wound Dressing
is an advanced wound care device comprised of a porous matrix
of cross-linked bovine tendon collagen and glycosaminoglycan
and a semi-permeable polysiloxane (silicone) layer. The
semi-permeable silicone membrane controls water vapor loss,
provides a flexible adherent covering for the wound surface
and adds increased tear strength to the device. The collagen-glycosaminoglycan
biodegradable matrix provides a scaffold for cellular matrix
and capillary growth.
Is the INTEGRA™
Bilayer Matrix Wound Dressing an FDA approved product?
Yes, the INTEGRA™ Bilayer Matrix Wound
Dressing received 510k clearance from the Food and Drug
Administration (FDA) in August 2002. To view the 510k clearance
letter, please click here.
What is INTEGRA™
Bilayer Matrix Wound Dressing indicated for?
INTEGRA™ Bilayer Matrix Wound Dressing
is indicated for the management of wounds including:
partial and full-thickness wounds, pressure ulcers, venous
ulcers, diabetic ulcers, chronic vascular ulcers, surgical
wounds (donor sites/grafts, post-Moh's surgery, post-laser
surgery, podiatric, wound dehiscence), trauma wounds (abrasions,
lacerations, second-degree burns, and skin tears) and draining
wounds. The device is intended for one-time use.
What are the key benefits of INTEGRA™
Bilayer Matrix Wound Dressing?
- Provides immediate wound coverage
- Highly conformable for various
anatomical sites
- Excellent performance in deep donor sites
- Exceptional strength and flexibility
- Room temperature storage
- Long shelf life
- Patients can begin rehabilitation with INTEGRA™
Bilayer Matrix Wound Dressing in place
- Provides excellent coverage over
exposed bone, tendon, cartilage and joints. Of 166 instances
of exposed internal structures that are ordinarily closed
with flaps, Integra closed 90% of them. (1)
- In a study of 107 patients having 158 documented individual
ulcers, 92% of patients healed completely by Integra alone
or with small subsidiary flaps (excluding poorly selected
patients). (1)
(1) Gottlieb, Marc, M.D. and Jennifer Furman. Successful
Management and Surgical Closure of Chronic and Pathological
Wounds using Integra. Journal of Burns & Surgical
Wound Care, 2004, Volume 3, No. 4
How does the INTEGRA™
Bilayer Matrix Wound Dressing work?
INTEGRA™ Bilayer Matrix Wound Dressing
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 into the body and replaced with protein
that is naturally produced by the skin. In approximately
14 to 21 days, the scaffold is eventually remodeled as
the patient's cells rebuild the damaged site and the silicone
layer removed. Complete wound closure occurs as epidermal
cells migrate from the wound edges. For larger wounds,
a thin skin graft of the person's epidermis may be applied
to the wound area to facilitate complete wound closure.
Wound closure is typically complete within 30 days. A
person is left with a healed wound created from their
own tissue.
Who makes INTEGRA™
Bilayer Matrix Wound Dressing?
INTEGRA™ Bilayer Matrix Wound Dressing
is manufactured and distributed by Integra LifeSciences
Corporation of Plainsboro, New Jersey.
Are there any special storage conditions
for INTEGRA™ Bilayer Matrix Wound
Dressing?
The product can be stored at room temperature
(2-30 degrees C).
How is the product sold?
INTEGRA™ Bilayer Matrix Wound Dressing
is sold in sheets - 2 inch x 2 inch (5 cm x 5 cm), 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).
It is offered as a 1 pack and a 5 pack. Each sheet is
supplied sterile, in single use, double peel packages
containing phosphate buffer.
.
Can you mesh the INTEGRA™
Bilayer Matrix Wound Dressing?
INTEGRA™ Bilayer Matrix Wound Dressing
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™
Bilayer Matrix Wound Dressing to conform to irregular surfaces
and may improve take on exudating wounds.
What is the shelf life of INTEGRA™
Bilayer Matrix Wound Dressing?
The product shelf life is 24 months. Lot
number and expiration date information are included
on the packaging.
Is INTEGRA™ Bilayer
Matrix Wound Dressing latex-free?
All raw materials used in the manufacture
of INTEGRA™ Bilayer Matrix Wound Dressing, 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).
To view Latex-Free Letter, please
click here
Is training required before use of the
INTEGRA™ Bilayer Matrix Wound
Dressing?
Training is required prior to using INTEGRA™
Bilayer Matrix Wound Dressing. The training program consists
of review of the Physician Training CD with your local
Plastic and Reconstructive Sales Specialist or review
of this website. Participation in the training program
will result in certification and the assignment of a certification
number. This certification number is required for order
placement.
Are there any contraindications for the
product?
The device should not be used in patients
with known sensitivity to bovine collagen or chondroitin
materials.
INTEGRA™ Bilayer Matrix Wound Dressing is not
indicated for use in third-degree burns.
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