Managed Care - May 2008 - (Page 53) TOMORROW’S MEDICINE Surgeons Now Have Glue To Keep Skin Grafts in Place Artiss, a fibrin product, is a breakthrough, allowing burn patients to avoid anesthesia, staples, and a subsequent operation to remove the staples Thomas Morrow, MD ost people dread a severe burn. Each year there are about 2.4 million burn injuries in the United States; half a million people require medical attention, and approximately 4,500 die. Skin grafts are one of the key therapies. They provide needed covering to the denuded tissue and help to prevent the loss of fluids and critical serum proteins and electrolytes. There are many types of skin grafts, including animal skin, donated human skin culture grafts, skin transplants from unburned areas, and cultured autologous grafts. M Gluing skin grafts in place Surgeons clear away the damaged tissue and basically cover the prepared area with the graft material. Grafts are typically attached using either filamentous or metal sutures, but both have drawbacks. Metal sutures must be removed — a painful process that often requires anesthesia. Filamentous sutures “dissolve” but can cause troublesome reactions. For years surgeons have yearned for a method to “glue” the skin graft in place, but available nonbiologic chemical glues such as cyanoacrylate and polyethylene glycol polymer that have been used successfully in other surgical arenas have failed to provide a solution for burn surgeons. If one were to attempt to list the desirable attributes of a tissue glue, he would list that it would be: easy to use, rapid acting, nontoxic in nature, lacking in immunologic, infectious or oncologic effects, able to be sprayed on large surface areas, and of course, biodegradable. It would also have to be at least as good as, and preferably better than, suturing methods that have stood the test of time. Of course a major attribute would include the ability for the skin graft to “take” and to have the strength to actually hold the skin to the damaged subcutaneous tissue. Physicians have long known that our bodies create a “glue” of sorts. One only has to observe a laceration to see that, shortly thereafter, substances in the blood create a sticky, rapidly setting adhesive seal. The basis for this natural adhesive is fibrin, a protein which, when activated by thrombin, rapidly binds to human tissue creating a natural adhesive. In fact fibrin was first described as a sealant in 1909 in Europe. The FDA approved Tisseel, the first fibrin product in the United States, in 1998. Since then, Crosseal and Costasis have been approved. These products are used for a variety of surgical procedures, such as hemostasis and sealing colonic anastomosis, but all have had some drawbacks for the unique needs of burn graft adhesion. A new product, Artiss (fibrin sealant, human) manufactured by Baxter Healthcare, was approved by the FDA on March 19, and is expected to be launched this summer. Artiss is specifically indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adults and children. It is not indicated for hemostasis. Artiss is available in two forms — a prefilled frozen syringe and a freeze-dried kit. The kit contains human sealer protein concentrate, synthetic fibrinolysis inhibitor solution, human thrombin and calcium chloride solution. In the kit version, the first two ingredients and the last two ingredients are reconstituted and combined just prior to use and then sprayed onto the wound. The surgeon has about one minute to apply and adjust the autologous Thomas Morrow, MD, is the immediate past president of the National Association of Managed Care Physicians. He has 23 years of managed care experience at the payer or health plan level. MAY 2008 / MANAGED CARE 53
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