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FDA Expands Label for Omnigraft Dermal Regeneration Matrix
The FDA has approved a new indication for the Omnigraft dermal regeneration matrix (Integra LifeSciences Corporation) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.
An estimated 29 million people in the U.S. have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention, and approximately 25% of them will experience a foot ulcer during their lifetime. Chronic diabetic foot ulcers are associated with tissue and bone infections and result in 50,000 amputations each year.
The FDA first approved the Integra dermal regeneration template (which the company now also calls Omnigraft) in 1996 for the treatment of life-threatening burn injuries when the use of a patient’s own skin for a graft was not possible. In 2002, the Integra dermal regeneration template was approved for a new indication to treat patients undergoing reconstructive surgery for burn scars when they cannot have skin grafts. Now, Omnigraft is approved to treat certain diabetic foot ulcers that last for longer than six weeks and do not involve exposure of the joint capsule, tendon, or bone, when used in conjunction with standard diabetic ulcer care.
The new indication for Omnigraft is based on a clinical study that demonstrated that the matrix device improved ulcer healing compared with standard diabetic foot ulcer care, which included cleaning and covering the wound with a surgical bandage and keeping weight off of the foot with the ulcer. In the study, 51% of patients treated with Omnigraft had healed ulcers after 16 weeks compared with 32% of patients treated with standard diabetic foot-ulcer care alone.
Adverse events observed in this study included infections, increased pain, swelling, nausea, and new or worsening ulcers.
Omnigraft should not be used in patients with allergies to bovine collagen or chondroitin because serious allergic reactions may occur. In addition, Omnigraft should not be used on infected wounds.
Source: FDA; January 7, 2016.