Managed Care - May 2008 - (Page 54) TOMORROW’S MEDICINE skin graft. The graft must then be held in place by gentle pressure for at least three minutes to ensure that Artiss sets properly and adheres to the surrounding tissue. The solidified fibrin sealant reaches its final strength about two hours after application. In the prefilled dual-chambered syringe version, the components mix themselves after thawing. These preparations differ from previous versions of fibrin-based products in that the fibrinolysis inhibitor slows the cure rate, allowing more time for manipulating the graft. Pivotal trial The pivotal trial, published in the Journal of Burn Care and Research in March 2008, reported that this new product demonstrated outcomes equal to those obtained using staples. The study consisted of 138 treated subjects, 94 male and 44 female. They ranged in age from 6 to 65 (median 29). All had burn wounds covering 40 percent or less of their total body surface area (TBSA), with a mean of 13.6. Study patients were required to have deep partial-thickness or full-thickness burn wounds that required excision and skin grafting. Each patient acted as his own case and control by using the Artiss method and staples on separate but comparable wounds measuring between 1 percent and 4 percent of the TBSA or a single wound measuring between 2 percent and 8 percent of TBSA, split into two equal portions. Both sites received seemingly identical autologous split-thickness sheet skin grafts with a specific thickness. The primary analysis was performed on the intent-to-treat population using a noninferiority endpoint for the statistical analysis. The safety profile and primary and secondary efficacy outcomes were similar for both the Artiss process and staples, with the exception of increased rate of graft complications in stapled areas, mainly as the result of retained staples. Patient significantly favored the Artiss process over staples. Artiss can be considered a new tool for the treatment of burns, one that appears to offer some distinct advantages in patient preference as well as ease of use. Since this is a human product made from pooled human plasma, there is, despite all of the procedures used to prepare it, a slight possibility of viral infections. Baxter uses screened plasma donors, multiple tests for the presence of certain infections, and a process to inactivate and remove certain viruses. Contraindications include intravascular administrations as well as known hypersensitivity to aprotinin. Future developments are expected to include devices that can rapidly isolate and concentrate a person’s own fibrin and thrombin. This approach, using a process and device named Cryoseal that is manufactured by Thermogenesis, is in phase 3 trials. An approach using genetic engineering is also in our future. These and other approaches to creating tissue adhesives and sealants will continue to revolutionize surgery and allow for other technological advances in surgical technique. Managed care implications Obviously most health plans do not get involved in managing the type of products used in reparative surgery such as repair of burn injuries. Potentially, this product will allow patients to avoid anesthesia and at least some of the costs of surgery: The staples and removal will be eliminated, thus creating significant cost offsets. Those of you involved in hospital formulary management will most likely be asked to include this in your hospital pharmacies because of patient and physician demand and the unique properties of a truly unique breakthrough. MC ADVERTISING INDEX FOREST LABORATORIES Bystolic 37–38 Namenda 27–28 HEALTH DIALOG Health Plans 15 JAZZ PHARMACEUTICALS Luvox CR 31–34 QUALITYMETRIC Health Outcomes Solutions 5 SANOFI-AVENTIS, U.S. MANAGED CARE C4 SOLVAY PHARMACEUTICALS Corporate 7 TAKEDA PHARMACEUTICALS AMERICA Actos C2–2 54 MANAGED CARE / MAY 2008
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