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Full Surface Adherence to Minimize Dead Space

ARTISS [Fibrin Sealant (Human)] is the first and only fibrin sealant FDA approved to adhere autologous skin grafts in burn surgery.

  • Indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age.1 ARTISS is not indicated for hemostasis1
  • Eliminates the need for staple application or removal2
  • Just thaw and warm—no mixing or reconstitution required1
  • 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 and/or hypersensitivity to any of the active substances or excipients

Clinical Evidence/Pivotal Study

The efficacy of ARTISS versus staples for skin graft adherence was demonstrated in a phase 3, multicenter, prospective, randomized, evaluator blinded clinical trial in 138 adult and pediatric burn patients. The study was designed to evaluate whether or not complete (100%) wound closure achieved 28 days after wound excision and skin grafting when ARTISS or staples were used.3

Efficacy Results

The proportion of test sites with complete wound closure* was similar between the 2 treatments (ARTISS, 43.3%; staples, 37%)

The lower limit of the 97.5% confidence interval of the difference between ARTISS and staples was -0.029, which is above the predefined noninferiority margin of -0.1.

*Full coverage of the wound with a contiguous layer of viable epithelium
†Blinded Review: reviewers were burn surgeons who were not involved with the study in any other way and who were unaware of treatments used in the study, treatment assignation, time point of assessment, and identity of the patient and operating surgeon

Adverse Reactions

Adverse reactions reported during clinical trials in greater than 1% for subjects were skin graft failure, hematoma and pruritus.

Study Conclusion

ARTISS is at least as efficacious as staples at the 97.5% one-sided level for complete wound closure by day 28.3

Comparison to Staples

 

Please click on link for detailed Important Risk Information

See more on the steps to prepare ARTISS for use

 

  1. ARTISS [Fibrin Sealant (Human)] full Prescribing Information, 08/2011.
  2. Data on file. Westlake Village, Calif: Baxter Healthcare Corp.
  3. Foster K, Greenhalgh D, Gamelli RL 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. J Burn Care Res. 2008;29(2):293-303.