Mechanism of Action

See how ARTISS works.

See how ARTISS [Solutions for Sealant] works.

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Featured Video

ARTISS use in a facelift procedure.

ARTISS [Solutions
for Sealant] use in
a facelift procedure.

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ARTISS Resources

ARTISS use on a radial forearm burn.

Brochure–
Application and benefits in burn surgery

Full Surface Adherence Eliminating Dead Space1,2

ARTISS [Solutions for Sealant] – first and only fibrin sealant custom designed for tissue adherence in plastic, reconstructive, and burn surgery.

  • Allows up to 60 seconds to manipulate and position the flap1-3
  • Full surface adherence eliminating dead space1,4
  • Reduces the incidence of hematoma and seroma compared to standard of care1,5
  • May reduce or eliminate the need for staples/sutures1,4,5
  • Improved patient satisfaction1,4,5
  • Frozen ready-to-use formulation—no mixing or diluting required5

Clinical Evidence/Pivotal Study

The efficacy of ARTISS [Solutions for Sealant] 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 [Solutions for Sealant] or staples were used.1

  • The proportion of test sites with complete wound closure* was similar between the 2 treatments
    (ARTISS [Solutions for Sealant], 43.3%; staples, 37%)
  • The pivotal study concluded ARTISS [Fibrin Sealant (Human)] is at least as efficacious as staples at the
    97.5% one-sided level for complete wound closure by day 28.1

Comparison to Staples

The pivotal study concluded that ARTISS [Solutions for Sealant] is at least as efficacious as staples at the 97.5 one-sided level for complete sound closure by day 28. The lower limit of the 97.5% confidence interval of the difference between ARTISS [Solutions for Sealant] 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


Dorsal Hand Burn Surgical Case

Steven Jeffery, BSc, MB ChB, FRCS, EPOPRAS, FRCS demonstrates ARTISS [Solutions
for Sealant] application prior to placing the skin graft on a dorsal hand burn. Sutures or
staples are not necessary.

 

Radial Forearm Burn Surgical Case

After applying a few staples to keep the skin graft properly positioned, Kevin Foster, MD, MBA,
FACS demonstrates application of ARTISS [Solution for Sealant] on the radial portion of the forearm.

 

See more on the steps to prepare ARTISS [Solutions for Sealant] for use

 

  1. Foster K, Greenhalgh D, Gamelli RL, et al. FS 4IU VH S/D Clinical Study Group. 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.
  2. Rohrich RJ, Shire JR, Desmond JC, et al. ARTISS improves flap adherence following rhytidectomy through full surface adherence between the wound bed and applied tissue, which eliminates areas of dead space often associated with hematoma and seroma: results of a phase 3, multicenter, prospective, randomized, clinical study. Paper presented at: American Association of Plastic Surgeons (AAPS) 90th Annual Meeting; April 9-12, 2011; Boca Raton, Fla.
  3. Data on file. Westlake Village, Calif: Baxter Healthcare Corp.
  4. Gibran N, Luterman A, Herndon D, et al. Comparison of fibrin sealant and staples for attaching split-thickness autologous sheet grafts in patients with deep partial- or full-thickness burn wounds: a phase ½ clinical study. J Burn Care Res. 2007;28(3):401-8.
  5. ARTISS [Solutions for Sealant]. Summary of Product Characteristics. Baxter International Inc: Vienna, Austria. October 2011.