SKIN SUBSTITUE

Integra® Dermal Regeneration Template

A bioengineered dermal matrix with over 25 years of clinical history in burn and reconstructive surgery

The IDRT System

Regenerating functional skin is critical to recovery for patients with severe burns and complex wounds. Integra® Dermal Regeneration Template (IDRT) is a bilayer matrix that gives surgeons an off-the-shelf alternative to autograft when donor tissue is limited or not available.

The matrix is made from a porous collagen and glycosaminoglycan scaffold, covered by a temporary silicone layer. Once applied to a prepared wound bed, the patient's own cells gradually populate the scaffold, forming a new vascularised dermal layer - the silicone layer is then removed and replaced with a thin epidermal graft to complete closure.

IDRT is indicated for the post-excisional treatment of life-threatening full-thickness or deep partial-thickness burns where sufficient autograft isn't available or desirable at the time of excision, and for reconstruction of full-thickness skin defects where the treating surgeon judges it will improve the reconstructive outcome.

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Engineered Bilayer Technology: Legacy & Evolution

Integra revolutionized the field of regenerative medicine and has grown to be a leading global provider with a broad portfolio for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

The Integra legacy is one of innovation, partnership, and responsiveness to patients and healthcare professionals in an ever-changing healthcare market. Following its introduction in 1996, Integra Dermal Regeneration Template started a legacy for skin substitutes that continues to evolve with alternative iterations and indications servicing a multitude of specialties in an effort to save lives.

Novel and Unique Composition

Integra Dermal Regeneration Template is a bilayer (two-layer) skin regeneration substitute.

The outer layer is made of a thin silicone that acts as the skin’s epidermis. It protects the wound from infection and controls both heat and moisture loss.

The inner layer is constructed of a complex matrix of cross-linked fibers. This novel ultra-pure bovine collagen and chondroitin-6-sulfate matrix was specifically engineered with optimized pore size, porosity, and structure to allow for regenerating dermal skin cells, which enables the regrowth of a functional dermal layer of skin.

Once dermal skin has regenerated, the silicone outer layer is removed and replaced with a thin epidermal skin graft.

Unmatched Clinical Performance

300+ STUDIES
Integra Dermal Matrix portfolio has an extensive, unparalleled body of evidence documenting successful clinical outcomes and safety—with over 40 years of basic science and clinical research.

With more than 300 level 1, 2, and 3 published peer-reviewed studies, Integra has consistently demonstrated clinical outcomes and safety in over 3,600 patients.

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FEATURES

Integra Technology Is a Bioengineered 3D Matrix Proven to Promote the Regeneration of Dermal Tissue

Biocompatibility
Ultra-pure Type I collagen with chondroitin-6-sulfate work together to provide a biocompatible structure with minimal inflammatory response to ensure formation of functional neodermis.1,2

Pore Size & Structure
Bioengineered with optimized pore size and structure within the matrix, resulting in cellular infiltration, vascular ingrowth and reduced contracture.2,3

Resorption Profile
The 3D matrix is resorbed while new tissue is being formed, resulting in neodermis. The remaining tissue is composed of the patient’s own cells and proteins.3

Physical Characteristics

Porosity
Overall density and size distribution of pores in a solid construct (i.e. matrix) determine how cells migrate. Pore sizes aligned with typical cell sizes are important for supporting a variety of essential cellular activities.

Integra’s controlled pore size and structure due to its bioengineered design offers a tighter distribution and optimized size for cellular migration and proliferation.8

Absorption
Cells and blood components prefer hydrophilic materials for attachment and infiltration. Integra offers a high hydrophilic structure which may allow for blood and cellular hydration of the matrix.9

Conformability
High bending and conformability allow for improved intimate contact with complex wound beds and structures (topographies) and a reduced risk of graft tenting or lifting.

2 Configuration & 4 Sizes

Integra Dermal Regeneration Template is offered in a non-meshed (standard) or meshed configuration called Meshed Dermal Regeneration Template.

Both non-meshed and meshed configurations are available in sizes:
2x2in (5x5cm)
4x5in (10×12.5cm)
4x10in (10x25cm)
8x10in (20x25cm)

CLINICAL

1st and Only Approved Skin Substitute

Integra Dermal Regeneration Template is the first and only skin substitute approved to treat third-degree burns and the repair of scar contractures.

Demonstrated Clinical Excellence

  • Significantly better clinical status in younger patients treated with Integra DRT versus autograft/allograft (n=20)4^
  • No incidence of late onset contractures in patients with extensive burns (mean duration of follow-up was 5.45 years, n=70)5
  • Shorter hospitalization and comparable mortality (despite greater average burn severity in the Integra DRT group) versus autografts (n=270)6
  • The rate of amputation was significantly lower in the Integra DRT group versus autograft / flap with 5.7% vs. 31.5%, (n=88)7

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^Lower metabolic rate, improved bone mineral composition, greater bone density and improved scarring

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