Integra -Description
Integra -Description

Integra® Dermal Regeneration Template is an advanced bilayer matrix consisting of a porous, three-dimensional dermal replacement layer and a temporary epidermal layer. The dermal replacement layer (collagen and glycosaminoglycan) is designed with a controlled porosity and defined degradation rate to promote neodermal formation. The epidermal layer (polysiloxane) provides a moisture and bacterial barrier.

• FDA-approved for partial- and full-thickness third-degree burns and reconstruction of scar contracture
• Biodegrades while being replaced with autologous tissue
• Promotes cellular growth and collagen synthesis
• Controls fluid loss
• Provides mechanical protection and a bacterial barrier

Integra® Dermal Regeneration 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® Dermal Regeneration 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.

This devices should not be used in patients with known sensitivity to bovine collagen or chondroitin materials. Integra® Dermal Regeneration Template should not be used on clinically diagnosed infected wounds.

Do not resterilize. Discard all opened and unused portions of the device. Do not use if the package seal is broken.

Excision of the wound must be performed thoroughly to remove all coagulation, eschar and nonviable tissue. Integra® Dermal Regeneration Template will not “take” (incorporate into the wound bed) to nonviable tissue. Leaving any remaining nonviable tissue may create an environment for bacterial growth. Hemostasis must be achieved prior to applying Integra® Dermal Regeneration Template. Inadequate control of bleeding will interfere with the incorporation of Integra® Dermal Regeneration Template.

There have been no clinical studies evaluating Integra® Dermal Regeneration Template in pregnant women. Caution should be exercised before using Integra® Dermal Regeneration Template in pregnant women. Such use should occur only when the anticipated benefit clearly outweighs the risk. In clinical trials, the use of Integra® Dermal Regeneration Template was evaluated in a small number of patients with chemical, radiation or electrical burns. A surgeon’s decision to use Integra® Dermal Regeneration 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® Dermal Regeneration Template should be applied on the day of excision. Delaying the application of Integra® Dermal Regeneration Template may substantially impair the take of the material.

Appropriate techniques to minimize pressure and shearing should be used to reduce the risk of mechanical dislodgement.

Placing the patient in hydrotherapy immersion may interfere with proper incorporation of the Integra® Dermal Regeneration 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® Dermal Regeneration Template must not be excised off the wound.

Complications are possible with the use of wound dressings including infection, chronic inflammation, allergic reaction, excessive redness, pain or swelling.

Integra® Dermal Regeneration Template has been found to be well tolerated in four prospective clinical trials involving 444 burn patients. There were no reports of clinically significant immunological or histological responses to the implantation of Integra® Dermal Regeneration Template. There were no reports of rejection of Integra® Dermal Regeneration Template.

Adverse events in the post-approval study were similar to those observed in the previous clinical trials and are common in populations of critically ill burn patients regardless of the type of treatment being used. There were no trends noted. There were six adverse events which were rated by the investigator as being related. These events were all single occurrences except for sepsis (2). These adverse events occurred in less than 1% of the safety population.

For the full list of Adverse Events, please see the Integra® Dermal Regeneration Template Instructions for Use.

Room temperature with a 24-month shelf life.

Burns
Reconstruction of scar contracture

Always handle Integra® Dermal Regeneration Template using aseptic technique. Peel open the outer pouch and remove the inner foil pouch using sterile technique. Place foil pouch flat on a sterile surface and peel it open. Remove product, including the protective polyethylene cover sheets. While holding the product with the tab, remove one polyethylene cover sheet. Turn the product and remove the second polyethylene cover sheet. Using the tab, the product can now be placed into a basin containing sterile saline solution. Carefully remove the tab from the product. Rinse the product by immersion in sterile saline for one to two minutes. Keep product in the basin until application.

Wound Excision
Excision must be made to the level of viable tissue and meticulous hemostasis must be achieved before application of Integra® Dermal Regeneration Template. Excisional techniques for Integra® Dermal Regeneration Template sites can be fascial, sequential or tangential. It is absolutely critical to the successful take of Integra® Dermal Regeneration Template that excision be complete and that no devitalized tissue remains. Complete hemostasis must be achieved before application of Integra® Dermal Regeneration Template. The presence of hematoma will cause loss of Integra® Dermal Regeneration Template in the affected area. Broad area cauterization that could decrease wound bed viability should be avoided.

Shaping Integra® Dermal Regeneration Template to Fit the Wound
Integra® Dermal Regeneration Template should be shaped accurately to fit the excised wound margins to minimize scarring at these margins. It should not be overlapped onto non-excised areas or onto other sheets of Integra® Dermal Regeneration Template. It is easily cut with sterile scissors by placing the sheet of Integra® Dermal Regeneration Template over the excised wound bed and cutting exactly to the edge.

Applying Integra® Dermal Regeneration Template to the Wound
It is critical that the collagen template layer be in direct contact with the excised wound. The silicone layer (identified by the black threads) must be placed out (away from the wound bed). Do not apply upside down; the black threads must be clearly visible. For optimal cosmetic results, place the Integra template so that the suture lines between Integra® Dermal Regeneration Template sheets lie in Langer’s lines. This will minimize the final appearance of the suture lines.

The Integra® Dermal Regeneration Template sheets are secured by staples or sutures placed in an interrupted fashion under slight tension. If the Integra® Dermal Regeneration Template has been meshed, care must be taken not to spread the mesh. Care should be taken to achieve a primary closure between Integra® Dermal Regeneration Template and adjacent unburned skin or between sheets of Integra® Dermal Regeneration Template. Suture or staple each sheet of Integra® Dermal Regeneration Template in place independently. The Integra® Dermal Regeneration Template sheets may also be affixed to one another to assure that there is no gap between sheets. Adjust the area to ensure that there is no undue tension on an individual piece of Integra® Dermal Regeneration Template. The material should readily adhere and conform to the wound surface. Any air bubbles should be carefully removed by moving them to the edge of the sheet. Dressings should be applied over Integra® Dermal Regeneration Template according to the protocol of the practitioner.

The inner dressing need not be disturbed unless there are problems requiring intervention. The attachment of the silicone layer should be examined. An antibacterial dressing may be used or the outer dressing can be soaked in an appropriate antimicrobial solution.

There should be no hydrotherapy immersion of the patient following Integra® Dermal Regeneration Template application while the silicone layer is in place. Mechanical dislodgment of Integra template should be avoided. Ambulation and physical therapy can be instituted according to the condition of the patient and judgment of the practitioner. All Integra® Dermal Regeneration Template sites must be securely covered with dressings before ambulation and/or physical therapy.

Staples or sutures should remain in place until the time of epidermal autografting. The staples or sutures help secure the silicone layer and decrease the likelihood of premature silicone layer separation.

The silicone layer of Integra® Dermal Regeneration Template may be removed when the collagen layer has been replaced by neodermis, usually 14 to 21 days after application. Removal of the silicone layer and grafting may take place immediately after formation of the neodermis, if epidermal autograft is available. The removal of the silicone layer may be postponed until donor sites for epidermal autograft area are available.

The clinician must be careful when removing the silicone layer. The silicone layer can usually be removed using only forceps. Generally, it should peel off easily. Difficulties in removal may indicate that neodermis formation is incomplete. However, if the silicone is difficult to remove, a forceps and scalpel may be used to gently separate the silicone layer from the neodermis. Caution must be employed to not remove the newly formed neodermal tissue when removing the silicone layer. Integra® Dermal Regeneration Template must not be excised off the wound.

Harvesting and Preparation of the Epidermal Autograft
Epidermal autograft can be taken from sites unsuitable for conventional autograft; for example, small areas from which a large intact sheet would be impossible. If possible, the area should be matched for color and type of skin.

A thin epidermal autograft should be taken at a thickness just sufficient to provide punctate bleeding of the donor site, typically 0.004″-0.006″ (0.10mm-0.14mm). Dermal tissue is not needed in the epidermal autograft and should be minimized.

Typically, the thin epidermal autograft may be meshed up to a 4:1 ratio. The meshed epidermal
autograft may be fragile and care should be taken in handling the graft.

Application of the Epidermal Autograft to the Neodermis
The epidermal autograft should be placed over the neodermis by spreading the meshed autograft. It should be spread as evenly as possible over the neodermis without leaving large open areas.

Completion of the epidermal autograft procedure should follow the standard protocol for full sheet or meshed autograft. The epidermal autograft should be anchored by sutures or staples. The dressing over the epidermal autograft should be similar to that used over conventional meshed autograft.

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