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Integra Skin - INTEGRA Burn Treatments

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.

Integra Skin - INTEGRA Burn Treatments

What is INTEGRA® Template?

Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
What is INTEGRA® Template?
Integra Skin - INTEGRA Burn Treatments
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.
Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Is the INTEGRA® Template an FDA approved product?
Integra Skin - INTEGRA Burn Treatments

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.


Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
What is INTEGRA® Template indicated for?
Integra Skin - INTEGRA Burn Treatments
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.
Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
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
    Integra Skin - INTEGRA Burn Treatments

    These results have been confirmed by frequent patient follow-ups over a 10-year period.
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
How does the INTEGRA® Template work?
Integra Skin - INTEGRA Burn Treatments
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.
Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Who makes INTEGRA® Template?
Integra Skin - INTEGRA Burn Treatments
INTEGRA® Template is manufactured and distributed by Integra LifeSciences Corporation of Plainsboro, New Jersey.
Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Are there any special storage conditions for INTEGRA® Template?
Integra Skin - INTEGRA Burn Treatments
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.
Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
How is the product sold?
Integra Skin - INTEGRA Burn Treatments
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.
Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Can you mesh the INTEGRA Template?
Integra Skin - INTEGRA Burn Treatments

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

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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
What is the shelf life of INTEGRA® Template?
Integra Skin - INTEGRA Burn Treatments
The product expiration date is 2 years. Lot number and expiration date information are included on the packaging.
Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Is INTEGRA® Template latex-free?
Integra Skin - INTEGRA Burn Treatments
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

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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Is training required before use of the INTEGRA® Template?
Integra Skin - INTEGRA Burn Treatments
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.

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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
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

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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments

Are there any contraindications for the product?
Integra Skin - INTEGRA Burn Treatments
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.

Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments

Is there patient information available on the product?
Integra Skin - INTEGRA Burn Treatments
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.

Integra Skin - INTEGRA Burn Treatments
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Integra Skin - INTEGRA Burn Treatments
Integra Skin - INTEGRA Burn Treatments

 
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