| 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™ Meshed Bilayer Wound Matrix?
What is INTEGRA™ Meshed Bilayer Wound Matrix?
INTEGRA™ Meshed Bilayer Wound Matrix
is an advanced wound care device comprised of a porous matrix
of cross-linked bovine tendon collagen and glycosaminoglycan.
The collagen-glycosaminoglycan biodegradable matrix provides
a scaffold for cellular matrix and capillary growth. The
meshed bilayer matrix allows drainage of wound exudate and
provides a flexible adherent covering for the wound surface.
Is the INTEGRA™ Meshed Bilayer Wound Matrix an FDA approved product?
The INTEGRA™ Meshed Bilayer Wound Matrix
received 510k clearance from the Food and Drug Administration
(FDA) in December 2008. To view the 510k clearance letter,
please
click here.
What is INTEGRA™ Meshed Bilayer Wound Matrix indicated for?
INTEGRA™ Meshed Bilayer Wound
Matrix 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. INTEGRA™ Meshed Bilayer Wound Matrix
may be used in conjunction with negative pressure wound
therapy. The device is intended for one-time use.
Refer to the products
Instructions for Use for full prescribing information
  What are the key
benefits of INTEGRA™ Meshed Bilayer Wound Matrix?
- May be used in conjunction with negative
pressure wound therapy
- Allows drainage of wound exudate
and provides a flexible adherent covering for the wound
surface
- Provides immediate wound coverage
- Highly conformable for various anatomical
sites
- Excellent performance in deep donor
sites
- Room temperature storage
- Long shelf life
- Patients can begin rehabilitation
with INTEGRA™ Meshed Bilayer Wound Matrix in place
- Provides 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)
(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™ Meshed Bilayer Wound Matrix work?
INTEGRA™ Meshed Bilayer Wound Matrix
is placed on a surgically debrided or excised wound, and
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. 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™ Meshed Bilayer Wound Matrix?
INTEGRA™ Meshed Bilayer Wound Matrix
is manufactured and distributed by Integra LifeSciences
Corporation of Plainsboro, New Jersey.
Are there any special storage conditions
for INTEGRA™ Meshed Bilayer Wound Matrix?
INTEGRA™ Meshed
Bilayer Wound Matrix is supplied sterile, in single
use, double peel packages containing phosphate buffer. Store
flat at room temperature (+10°C to +30°C).
How is the product sold?
INTEGRA™ Meshed Bilayer Wound Matrix
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.
What is the shelf life of INTEGRA™ Meshed Bilayer Wound Matrix?
The product shelf life is 24 months from
date of manufacture. Lot number and expiration date information
are included on the packaging.
Is INTEGRA™ Meshed Bilayer Wound Matrix latex-free?
All raw materials used in the manufacture
of INTEGRA™ Meshed Bilayer Wound Matrix, 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™ Meshed Bilayer Wound Matrix?
Training is required prior to using INTEGRA™ Meshed Bilayer Wound Matrix. 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?
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