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ARTISS [Fibrin Sealant (Human)] |
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ARTISS [Fibrin Sealant (Human)], Vapor Heated, Solvent Detergent Treated, (ARTISS) is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein (Human) and Thrombin (Human), mimic the final stage of the blood coagulation cascade.
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- ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds, resulting from burns in adult and pediatric populations.
- ARTISS is not indicated for hemostasis.
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- ARTISS provides full surface adhesion of the graft to the wound bed, closing the space that exists when grafts are attached using point fixation techniques such as staples2
- ARTISS sets in approximately 60 seconds, and is specifically designed for use in burn surgery allowing the surgeon time to manipulate and position the graph prior to polymerization1
- ARTISS does not require staple fixation of donor graft, eliminating need for applying and removing staples2
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Upon mixing Sealer Protein (Human) and Thrombin (Human), soluble fibrinogen is transformed into fibrin that adheres to the wound surface and to the skin graft to be affixed. Due to the low thrombin concentration, polymerization of ARTISS will take approximately 60 seconds. |
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The findings of a Phase 3 pivotal study demonstrated that ARTISS is safe for attaching skin grafts in burn patients with partial or full thickness burn wounds. No serious adverse events were reported in the 12-month follow-up period after the Phase 3 study. |
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| Important Safety Information |
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- For Topical Use Only. Do not inject ARTISS directly into blood vessels. Intravascular application of ARTISS may result in life-threatening thromboembolic events.
- Do not use ARTISS in individuals with a known hypersensitivity to aprotinin.
- 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.
- Apply only as a thin layer.
- Use caution when applying with pressurized gas.
- Exposure to solutions containing alcohol, iodine or heavy metals may cause ARTISS to be denatured.
- Adverse reactions occurring in greater than 1% of patients treated with ARTISS were skin graft failure and pruritus.
Please see accompanying ARTISS Prescribing Information for full prescribing details.
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- ARTISS [Fibrin Sealant (Human)] full Prescribing Information, 03/2008.
- Foster K et al. Efficacy and safety of a fibrin sealant for adherence of autologous skin grafts to burn wounds: results of a phase 3 clinical study. Journal of Burn Care and Research 2008; March/April 2008; Volume 29, Number 2.
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Baxter and ARTISS are registered trademarks of Baxter International Inc. |
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