| 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® Template?
What is INTEGRA® Template?
Integra® Dermal Regeneration
Template, available in Meshed and Non-Meshed configurations
(Integra® Template) is a bilayer membrane
system for skin replacement. The dermal replacement layer
is made of a porous matrix of fibers of cross-linked bovine
tendon collagen and glycosaminoglycan (chondroitin-6-sulfate)
that is manufactured with a controlled porosity and defined
degradation rate. The epidermal substitute layer is made
of thin polysiloxane (silicone) layer to control moisture
loss from the wound.
Is the INTEGRA® Template an FDA approved product?
In 1996, the US Food and Drug Administration
(FDA) approved the use of INTEGRA® Dermal Regeneration
Template for the treatment of life threatening burn injuries.
Since then, nearly 10,000 patients have been successfully
treated using the INTEGRA® Template.
In 2002, the FDA approved the use of INTEGRA ®
Dermal Regeneration Template to include the reconstruction
of scar contractures. This new indication provides relief
for thousands of individuals living with disabling scarring
from prior burns.
In 2014, the FDA approved the use of
Integra® Meshed Dermal Regeneration Template
for the treatment of life threatening bur injuries and
the reconstruction of scar contractures.
What is INTEGRA® Template indicated for?
INTEGRA® Template
is indicated for the post-excisional treatment of life threatening
full-thickness or deep partial-thickness thermal injuries
where sufficient autograft is not available at the time
of excision or not desirable due to the physiological condition
of the patient.
INTEGRA® Template is indicated for
the repair of scar contractures when other therapies have
failed, or when donor sites for repair are not sufficient
or desirable due to the physiological condition of the patient.
What are the key benefits of INTEGRA® Template?
- The permanent regeneration of dermal skin
- Thinner skin grafts resulting
in less scarring at the donor site
- Faster healing donor sites
- Immediate physiological wound
closure without risking the loss of donor material
- Patients can begin rehabilitation
with INTEGRA® Template in place
- No reports of rejection
- No immediate need to create donor site wounds
- Donor sites heal faster and can
be harvested more frequently
- Post excisional use of INTEGRA®
Template does not require the use of temporary
coverings such as allograft, xenograft or synthetic dressings
These results have been confirmed by frequent patient
follow-ups over a 10-year period.
How does the INTEGRA® Template work?
When INTEGRA® Template is placed on a wound
where burned or scarred skin has been removed, INTEGRA provides
the needed framework for the blood vessels and dermal skin
cells to re-grow into a new skin layer. The silicone outer
layer temporarily closes the wound to ward off infection
and control fluid and heat loss.
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, new dermal skin is produced and the silicone layer
can be removed. A thin skin graft of the person's epidermis
is applied to the wound area to complete the procedure.
In total, the two surgical procedures are typically completed
within 30 days. A person is left with flexible growing
skin and minimal damage at the skin graft donor sites.
Who makes INTEGRA® Template?
INTEGRA® Template
is manufactured and distributed by Integra LifeSciences
Corporation of Plainsboro, New Jersey.
Are there any special storage conditions
for INTEGRA® Template?
Yes, the product must be stored flat under
refrigeration at 35 degrees - 46 degrees F (2-8 degrees
C).
It must be protected from freezing.
How is the product sold?
INTEGRA® Template
is sold in sheets - 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).
In the United States, it is offered as a 1 pack and a
5 pack. Outside the United States, it is only sold 1 per
box. Each sheet is packaged in a foil pouch containing
approximately 250 mL of 70% isopropyl alcohol. Each sterile
foil pouch is packaged in a sealed outer chevron-style
pouch.
Can you mesh the INTEGRA Template?
INTEGRA® Template 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® Template
to conform to irregular surfaces and may improve take
on exudating wounds.
DO NOT re-mesh the pre-meshed product
What is the shelf life of INTEGRA® Template?
The product expiration date is 2 years.
Lot number and expiration date information are included
on the packaging.
Is INTEGRA® Template
latex-free?
All raw materials used in the manufacture
of INTEGRA ® Template, 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® Template?
The FDA requires physicians to be trained
prior to using INTEGRA® Template. 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.
Have clinical trials been performed on
the INTEGRA® Template?
INTEGRA has been evaluated in over 1,200 wound sites
in 444 burn patients in a series of 4 studies:
- Multicenter Safety and Efficacy Clinical Trial (Pivotal)
- Anatomic Site Study
- Meshed vs. Sheet INTEGRA® Template study
- Postapproval Study
It also has been evaluated in a Reconstructive Surgery
Study which evaluated the clinical and histological
outcomes in 20 consecutive patients (30 anatomical sites)
whose scars and contractures were treated with INTEGRA®
Template. A Retrospective Contracture Reconstruction
Survey was performed as well.
Please see IDRT
Package Insert for more information
Are there any contraindications for the
product?
Use of INTEGRA® Template is contraindicated
in patients with known hypersensitivity to bovine collagen
or chondroitin materials.
INTEGRA® Template should not be used on clinically diagnosed
infected wounds.
Is there patient information available
on the product?
We do have a patient
brochure for those considering the procedure. A
patient website is also available - www.integraskin.com
- which provides a resource for those looking for information
on different treatment options for burns and scar contractures.
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