FDA Approves New Skin Graft Adhesive for Burns
Artiss allows surgeons more time to position skin grafts before adherence begins
FRIDAY, March 21 (HealthDay News) -- The U.S. Food and Drug Administration announced this week that it has approved a new tissue adhesive, Artiss, for use in attaching skin grafts to wound sites of burn patients.
Artiss, a fibrin sealant, contains the blood-clotting proteins thrombin and fibrinogen, which help secure skin grafts to the burn site. However, the lower concentration of thrombin in Artiss compared to other fibrin sealants means that the product allows surgeons more time to approximate skin grafts over the burn site before the grafts begin to adhere to the tissue. In addition, Artiss contains aprotinin, a protein that acts to delay the breakdown of blood clots.
A multicenter clinical trial of Artiss evaluated the drug's ability to attach skin grafts to wound sites in 138 patients. On each patient, one skin graft was attached using Artiss while a second graft was fixed with surgical staples. The results showed that Artiss was comparable to surgical staples in allowing complete wound closure.
"The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites," explains Jesse L. Goodman, M.D., director for the FDA's Center for Biologics Evaluation and Research. "The approval also provides an additional choice for health care professionals in providing burn treatment."
Artiss is manufactured by Baxter Healthcare Corporation in Deerfield, Ill.