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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.
Rod J. Rohrich, MD1, James R. Shire, MD2, Julian C. Desmond, Ph.D3, Laura Silvati-Fidell3, Steve Zvi Abrams, MD3, Davis B. Nguyen, MD4, T Roderick Hester, Jr., MD5.
1UT Southwestern Medical Center, Dallas, TX, USA, 2Shire Facial Plastic Surgery, Chattanooga, TN, USA, 3Baxter Healthcare Corporation, Westlake Village, CA, USA, 4Linden Clinic, Beverly Hills, CA, USA, 5Paces Plastic Surgery, Atlanta, GA, USA.

PURPOSE:
Plastic surgeons have shown considerable interest in products that could aid in tissue adherence. To investigate the possibility that a low-thrombin concentration fibrin sealant could improve flap adherence following rhytidectomy surgery, a Phase 3 clinical study was performed evaluating the efficacy and safety of ARTISS (Fibrin Sealant VH S/D 4 s-apr, a 2-component fibrin sealant with 4 U/ml thrombin) in 75 subjects. Based on the results of an exploratory Phase 2 study, postoperative drainage was used as an objective surrogate marker of tissue adherence and elimination of dead space.
METHODS:
The primary efficacy endpoint was comparison of the total drainage volume for each side of the face at 24h postsurgery. A split-face study design was employed, where 1 side of a subject’s face was treated with ARTISS and the other received only standard of care (SoC). Pressure dressings were not permitted. Subjects were followed postoperatively for 14 days.
RESULTS:
A statistically significant difference in drainage volumes was observed, favoring the side of the face treated with ARTISS. A mean ± standard deviation (SD) volume of 7.7 ± 7.4 mL drained after 24h at the ARTISS-treated sides of the face, compared to a mean volume of 20.0 ± 11.3 mL at sides of the face receiving SoC alone (p < 0.0001). Assuming that <=15 mL of drainage in the first 24h postsurgery for a single side of the face would preclude the need for a drain, these data suggest that the use of ARTISS reduces drainage volumes from a level requiring the placement of a drain (20.0 mL) to a level well below the threshold for drain justification (7.7 mL). Investigators recorded the presence of hematoma/seroma throughout the follow-up period. A total of 7 hematoma/seroma events in a total of 5 subjects occurred on the ARTISS-treated sides of the face (1 hematoma in 1 subject; 6 seromas in a total of 4 subjects). For the SoC-receiving sides of the face, 8 events occurred in a total of 8 subjects (4 hematomas in a total of 4 subjects; 4 seromas in a total of 4 subjects). The difference between the paired proportions was not statistically significant. The safety profile of ARTISS was excellent. A total of 11 adverse events (AEs) in 6 subjects were reported on sides of the face treated with ARTISS. One serious AE occurred on the side of the face that received ARTISS. A total of 12 AEs in 11 subjects were reported on sides of the face receiving SoC.
CONCLUSION:
ARTISS is safe and efficacious for use in rhytidectomy. Adjuvant ARTISS use reduces drainage volumes in the 24h immediately following rhytidectomy to a level that may preclude the need for drain placement. This is achieved without the use of pressure dressings and without a coincident increase in the incidence of hematoma or seroma. This implies that ARTISS reduces localized fluid accumulation through full surface adherence and dead space elimination between the wound bed and tissue flap, rather than merely preventing fluid from reaching a drain.


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