INTEGRA® Dermal Regeneration Template (Patients)

Integra Dermal RegenerationTemplate




Introduction
The first and only FDA approved tissue engineered product for burn and reconstructive surgery

An inspired new approach to dermal regeneration

  • INTEGRA® Dermal Regeneration Template is an innovative bilayer matrix that provides a scaffold for dermal regeneration
  • INTEGRA® Dermal Regeneration Template is a biodegradable template that induces organized regeneration of dermal tissue by the body
  • INTEGRA® Dermal Regeneration Template provides immediate wound closure

Increases wound management options

  • An alternative to allograft or standard STG autograft
  • Minimal donor site morbidity
  • Able to reserve available donor sites for sheet grafts

The only approved skin substitute that regenerates dermis

  • Allows early wound excision
  • Immediate closure of the wound
  • Controls fluid loss
  • The patient is physiologically improved, allowing for early ambulation and rehabilitation

Proven in extensive clinical trials*

  • The safety and effectiveness of INTEGRA® Dermal Regeneration Template were evaluated in 444 patients in four clinical trials with the following results:
    • No scar formation appeared in the histological specimens in the pivotal trial1
    • The median take of INTEGRA® Dermal Regeneration Template was comparable to conventional autograft2
    • The median take of INTEGRA® Dermal Regeneration Template was 95% overall in the anatomic site study3
    • Epidermal autograft had successful take in 90.5% of the sites2
    • No reports of rejection of INTEGRA® Dermal Regeneration Template4

Worldwide experience

  • Almost 1,000 patients treated with INTEGRA® Dermal Regeneration Template
  • Regulatory approval in over 30 countries, with approval in additional countries pending
  • CE Mark certification in Europe awarded in March 1998

Experts discuss INTEGRA® Dermal Regeneration Template
"In our burn center, INTEGRA® Dermal Regeneration Template has replaced allograft in major burns and has produced long-term results as good as sheet autografts, using very thin meshed autografts from donor sites which heal within a week. Hypertrophic scarring doesn't occur with successful application of INTEGRA® Dermal Regeneration Template."
- David Heimbach, MD, Director
University of Washington Burn Center Harborview Medical Center
Seattle, Washington

"Think donor sites. The ultra-thin epidermal autograft allows the donor site to heal in five or six days. Dermal tissue is not needed in the epidermal autograft and is in fact, undesirable and should be minimized."
- Arnold Luterman, MD, Director University of South Alabama Mobile, Alabama

References
1. Stern R. McPherson M, Longaker,MT. Histologic study of artificial skin used in the treatment of full thickness thermal injury. J Burn Rehabil. 1990; 11:7-13
2. Heimbach D, Luteman A, Burke JF, et al. Artificial dermis for major burns: a multi-center randomized clinical trial. Ann Surg 1988; S208:313-320
3. Data on file, Integra LifeSciences Corporation
4. Michaeli D, McPherson M. Immunlogic study of artificial skin used in the treatment of thermal injuries. J Burn Care Rehabil. 1990;11:21-26.

Part Number: 32021, 32025, 34051, 34055, 34101, 34105, 38101, 38105

For more information, please contact Integra Customer Service at 877-444-1122 or 609-275-9004.