Slow Setting Fibrin Sealant Treats Burn Patients

An innovative slow-setting fibrin sealant has been developed to adhere skin grafts to the exposed wound bed in adult and pediatric burn patients.

Artiss is a biologically active sealant consisting of human fibrinogen and low concentration human thrombin indicated for autologous skin grafts to surgically prepared wound beds resulting from burns. Artiss allows for the delayed setting and controlled manipulation of skin grafts for approximately 60 seconds (relative to rapid-setting fibrin sealants, which set in 5 to 10 seconds). Skin grafts can be fixed without the use of staples or sutures, which may help reduce post-operative complications and patient anxiety about pain during staple removal. The sealant is available in two forms: a pre- filled frozen syringe formulation and a lyophilized form. Both dosage forms, once prepared and ready to use, can be sprayed, thus enabling application in a thin and even layer.

Artiss is not indicated for hemostasis and is prohibited for intravascular application, which may result in life-threatening thromboembolic events. Contraindications include individuals with a known hypersensitivity to aprotinin. Moreover, since Artiss is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Adverse reactions occurring in greater than 1% of patients treated with Artiss were skin graft failure and pruritus. Artiss is a product of Baxter Healthcare Corporation (Deerfield, IL, USA) and has been approved by the U.S. Food and Drug Administration (FDA).

"Artiss is a safe and effective alternative to staples, reducing discomfort among burn patients requiring skin grafts,” said Ron Lloyd, general manager of biosurgery at Baxter. "This is another example of Baxter's scientific leadership in specialty biologic products, serving needs of patients and physicians.”

FDA approval was granted based on a prospective, randomized, controlled and blinded phase III study conducted by researchers at the University of Cincinnati (OH, USA), which compared the use of Artiss to staples in 138 burn patients requiring skin grafting. Frequent adverse events, seen in both treatment groups, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures. The study results were published in the March/April 2008 issue of The Journal of Burn Care and Research.


Related Links:
Baxter Healthcare Corporation
University of Cincinnati