A Leg is Saved with the Help of Integra® Dermal Regeneration Template

Margo Casselman was only eight years old in 2000 when a horrific car accident nearly led to the amputation of her leg. “The car we were in got T-boned by another car that ran a red light. The vehicle I was in rolled, and I was ejected and ended up underneath the vehicle,” Margo recalls.

Her leg was broken in numerous places, and her skin had been stripped from the muscles and bones underneath. For most doctors who examined her, amputation of her injured leg seemed the only option. But Margo’s parents were determined to save her leg if possible.

That’s what led them to Dr. Marc Gottlieb. At the time, Integra® Dermal Regeneration Template (IDRT) was only a few years old and 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.  Luckily for Margo, Dr. Gottlieb had learned a lot through those early years of use and thought it would be a solution for helping repair her leg. He was right. It provides a framework for the dermal skin cells to regrow into a new skin layer. Its silicone outer layer temporarily closes the wound, until a few weeks later, when a thin layer of skin graft can complete the healing process.

Twenty years later, Margo hardly thinks about her accident. “I can do anything, and I do everything. The injuries I sustained from the car accident have neither held me back nor defined me in any way.”

Note: Clinical results may vary.

Product Information

Note: The results presented herein are case-specific and should not be used to draw general conclusions as to clinical outcomes

Description

Integra® Dermal Regeneration Template (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 athin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is provided sterile and non-pyrogenic. The inner foil pouch and product should be handled using sterile technique. Integra template should not be re-sterilized.

 

Indications

Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermalinjuries 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 also 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.

 

Contraindications

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.

 

Warnings

Excision of the wound must be performed thoroughly to remove all coagulation eschar and nonviable tissue. Integra template will not “take” to nonviable tissue. Leaving any remaining nonviable tissue may create an environment for bacterial growth. Hemostasis must be achieved prior to applying Integra template. Inadequate control of bleeding will interfere with the incorporation of Integra template.

 

Precautions

There have been no clinical studies evaluating Integra template in pregnant women. Caution should be exercised before using Integra template in pregnant women. Such use should occur only when the anticipated benefit clearly outweighs the risk. In clinical trials, the use of Integra template was evaluated in a small number of patients with chemical, radiation, or electrical burns. A surgeon’s decision to use Integra template on these wounds should be based on their evaluation of the wound and its suitability for excisional therapy, the likelihood that a viable wound bed will be created by excision, and whether the possible benefit outweighs the risk in this patient population.

Integra template should be applied on the day of excision. Delaying the application of Integra template may substantially impair the take of the material. Appropriate techniques to minimize pressure and shearing should be used to reduce risk of mechanical dislodgement.

Placing the patient in hydrotherapy immersion may interfere with proper incorporation of the Integra template and cause premature separation of the silicone layer and nonadherence of the template. Caution must be employed to not remove the newly formed neodermal tissue when removing the silicone layer. Integra template must NOT be excised off the wound. The extent of scarring associated with the use of this product has not been determined.