New Medical Adhesive Aids Skin Grafts for Burn Patients
The Food and Drug Administration on March 19 approved Artiss, a fibrin sealant that will adhere to skin grafts for adult and pediatric burn patients. Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in blood clotting; Artiss, from Baxter Healthcare, contains a lower concentration of thrombin, which gives surgeons about 60 seconds to position the grafts before they begin to adhere to the skin. (Other fibrin sealants allow only 10 seconds, Baxter says.) Artiss also contains a synthetic protein, aprotinin, that delays the breakdown of blood clots.
Baxter said the product allows grafts to be fixed in place without staples or sutures, which may help to prevent post-operative complications and patients' anxiety about pain during staple removal. The company will launch Artiss at the American Burn Association's 40th Annual Meeting, April 29–May 2 in Chicago.
"Artiss is a safe and effective alternative to staples, reducing discomfort among burn patients requiring skin grafts," said Ron Lloyd, general manager of Baxter's BioSurgery business. "This is another example of Baxter's scientific leadership in specialty biologic products, serving needs of patients and physicians."
FDA based its approval on Phase III study results that were published in the March/April 2008 issue of The Journal of Burn Care and Research. The study evaluated Artiss' performance against the use of staples in 138 burn patients requiring skin grafting, the Deerfield, Ill.-based company said.
"The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "The approval also provides an additional choice for health care professionals in providing burn treatment."