A fibrin sealant recently approved by the Food and Drug Administration for adhering autologous skin grafts in pediatric and adult burn patients provides an alternative to staples and sutures, according to the agency.
The sealant, derived from pooled human plasma, will be available in July and will be marketed under the trade name Artiss by Baxter Healthcare Corp.
Approval was based on a multicenter study of 138 patients whose mean age was 31 years (15% of the patients were aged 7–18 years). Each patient had one split-thickness skin graft attached with surgical staples and another attached with Artiss.
Artiss was determined to be as good as staples in attaining complete wound closure, according to the FDA: At 28 days, 45% of the Artiss-treated wounds and 37% of the stapled wounds had completely closed.
Adverse reactions with Artiss were skin graft failure (5 of the 138 patients) and pruritus (2 of the 138 patients).
Artiss is almost identical to Tisseel, another fibrin sealant manufactured by Baxter, but contains a much lower concentration of thrombin (4 IU/mL vs. 500 IU/mL in Tisseel), so it provides surgeons “more time to position skin grafts over burns before the graft begins to adhere to the skin,” according to the FDA. Artiss contains aprotinin, a fibrinolysis inhibitor. It is applied in a thin layer.
The availability of Artiss “can help surgeons using a fibrin sealant to fine-tune graft placement on burn sites,” Dr. Jesse L. Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in an FDA statement announcing the approval.
The warnings and precautions section of the Artiss label points out that because it is derived from human plasma, it potentially can transmit infectious diseases and, theoretically, the agent that causes Creutzfeldt-Jakob disease. It is for topical use only and is not approved for hemostasis.
At press time, Baxter did not have a price for Artiss.