“Mom, don’t look at my leg.”

Margo Casselman was only eight years old when a car accident left her trapped and dragged underneath her family’s vehicle as it spun on its side in the middle of an intersection. A car had run a red light and T-boned them, causing Margo to fly out of the vehicle on impact.

As a result, she sustained what is known as a “degloving injury” on her left lower extremity – the skin around her knee and leg had been stripped off her muscle and bone.

Margo’s injuries were so severe that the first few surgeons the Casselmans met after the accident told them that her leg would be impossible to salvage – they would have to amputate.

But unlike the other surgeons who had assessed Margo’s condition, Dr. Marc Gottlieb came out of Margo’s room smiling. After spending five or six hours trying to determine a course of action for Margo’s treatment, Dr. Gottlieb decided to use Integra.

He and his team had been using Integra for four years prior to Margo’s injury, which gave them a good idea of how it would work. “[Margo’s] situation,” Dr. Gottlieb says, “was the perfect place to use it.”

And Margo and her parents are incredibly grateful for Dr. Gottlieb and his use of Integra.

“His level of creativity and innovation were absolutely critical to this case.” Margo’s father says. “And it’s that same kind of creativity and innovation with a product like Integra that makes all the difference in people’s lives.”

Integra worked so well for Margo that her injuries have never held her back in her daily life, even now 19 years later. “I can do anything. And I do do everything,” she says.

Learn more about Margo’s road to recovery in the video above.

Integra template is indicated for the postexcisional 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 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.

Integra template is also marketed as Integra® Omnigraft™ Dermal Regeneration Matrix. Omnigraft is indicated for the use in the treatment of partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic care.

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 and Precautions
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.

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 to 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.

The extent of scarring associated with the use of this product has not been determined.

Adverse Events

Burn Patients
Integra template has been found to be well tolerated in 4 prospective clinical trials involving 444 burn patients. There were no reports of clinically significant immunological or histological responses to the implantation of Integra template. There were no reports of rejection of Integra template.

Adverse events reported in the Integra template clinical trials include death, sepsis, apnea, heart arrest, pneumonia, kidney failure, multisystem failure, and respiratory distress. With the exception of wound fluid accumulation, positive wound cultures, and clinical wound infection, none were directly related to the use of Integra template.

In these clinical trials, data were collected regarding wound infection. The consequences of infection at sites treated with Integra template included partial or complete loss of take (incorporation into the wound bed) of

Integra template. Infection rates in sites treated with Integra template in these three clinical trials supporting the PMA ranged from 14 to 55%. The overall infection rate for the Postapproval Study was 16.3%.

Adverse events in the Postapproval study were similar to those observed in the previous clinical trials and are common in populations of critically ill burn patients regardless of type of treatment 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 occurring in <1% of the safety population.

Incidence of adverse events occurring in >1% of the safety population in the Post-approval Study are as follows: Sepsis (23.1%), Death (13.9%), Infection (2.8%), Thrombophlebitis (2.8%), Kidney Failure (2.8%), Necrosis (2.3%), Hemorrhage (2.3%), Heart Arrest (1.9%), Apnea (1.9%), Pneumonia (1.9%), Allergic Reaction (1.4%), Fever (1.4%), Multisystem Failure (1.4%), Atrial Fibrillation (1.4%), Gastrointestinal Hemorrhage (1.4%), Kidney Abnormal Function (1.4%).

Contracture Release Patients
The following adverse events were reported in a Reconstructive Surgery Study involving 20 patients with 30 anatomical sites and a Retrospective Reconstruction Contracture Survey involving 89 patients and 127 anatomic sites.

Incidence of adverse events in the Reconstructive Contracture Surgery Study and Retrospective Contracture Reconstruction Survey are as follows: Infection (0.0%), Fluid under Silicone Layer (0.0%), Partial graft loss (Integra) (0.0%), Failure to take (Integra) (0.0%), Shearing/Mechanical shift (3.3%), Hematoma (16.7%), Granulation tissue formation (0.0%), Delayed Healing (0.0%), Separation of the Silicone Layer (0.0%), Seroma (0.0%), Pruritis (0.0%), Epidermal autograft loss >15% (6.7%), Epidermal autograft loss <15% (23.3).

There were no infections reported in the Reconstructive Surgery Study and the reported infection rate was 20.5% in the Retrospective Contracture Reconstruction Survey. No deaths were reported.

Diabetic Foot Ulcer Patients
All adverse events that were reported in the study evaluating Omnigraft for the treatment of diabetic foot ulcers at a frequency of ≥ 1% in either cohort are presented in Table 1 in the Instructions for Use.

This table includes adverse events that were both attributed to and not attributed to treatment.

The most common adverse events experienced by patients treated with Omnigraft were: wound infection (15%); new, worsening, or recurring wounds (14%); pain around the wound (9%); infection beyond the wound (either cellulitis or osteomyelitis, 14%); swelling (5%); nausea (5%); worsening health condition (4%). These adverse events occurred in a similar or lower percentage of patients treated with Omnigraft compared to patients treated with standard wound care alone.

The sale of Integra template is restricted to clinicians who have completed a company sponsored training program. Product training is available at ilstraining.com.

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