|89th Annual Meeting Abstracts
A Phase 2, Endpoint-Exploration, Multicenter, Prospective, Randomized, Evaluator-Blinded Clinical Study To Evaluate The Efficacy And Safety Of Adjuvant ARTISS Use In Facial Rhytidectomy
Zachary Gerut, MD, FACS1, Julian C. Desmond, Ph.D2, Laura Silvati-Fidell, MS, MA2, Judith Jill Sosa2, Steve Zvi Abrams, MD2, Roderick Hester, Jr., MD, FACS3.
1Albert Einstein Medical Center, New York, NY, USA, 2Baxter Healthcare Corporation, Westlake Village, CA, USA, 3Places Plastic Surgery, Atlanta, GA, USA.
Fibrin sealants have been used in surgical procedures for decades. Plastic surgeons have shown considerable interest in products that could aid adherence of wound surfaces. Potential advantages of fibrin sealants in plastic surgery include: prevention of hematomas; decreased fluid collection and elimination of the need for drains by reducing the dead space under the skin flap; and shorter recovery times. To investigate these possibilities, a Phase 2, endpoint-exploration, multicenter, prospective, randomized, evaluator-blinded clinical study was performed to evaluate the efficacy and safety of ARTISS (Fibrin Sealant VH S/D 4 s-apr, a 2-component fibrin sealant with 4 IU/ml human thrombin) in improving tissue plane adherence in a total of 45 subjects undergoing rhytidectomy.
The study design was a split-face rhytidectomy, where 1 side of a subject’s face was treated with ARTISS and the other received only standard of care (SoC). Thereby, each subject served as his/her own control. Subjects were followed postoperatively for 14 days, with evaluations and study procedures occurring on Day 0 (day of surgery), 1, 3, 5, 7, 10, and 14. A variety of assessments investigated the impact of ARTISS in rhytidectomy. Drainage volumes for each side of the face were analyzed, as an indicator of tissue plane adherence and elimination of dead space.
A statistically significant difference in drainage volumes was observed, favoring the side of the face treated with ARTISS. A mean ± SD volume of 11.4 ± 14.8 ml drained after 24 hours from ARTISS-treated sides of the face, compared to a mean volume of 24.3 ± 22.9 ml at SoC sides of the face (p=0.0010). No incidence of hematoma/seroma was observed on sides of the face treated with ARTISS, compared to 8 (18%) subjects who were diagnosed with hematoma/seroma (varying severity) on the sides of the face that received SoC alone (p=0.014). Using standardized photographs, 5 blinded, expert reviewers independently graded and compared levels of ecchymosis for each side of each subject’s face. Lack of correlation between the outcomes reported by the 5 blinded reviewers rendered the assessment of postoperative ecchymosis inconclusive. A 2 point discrimination test, used to determine changes in postoperative skin sensation, suggested slight improvements in sensation perception on the sides of the face that had been treated with ARTISS. Generally, subjects reported lower pain levels and less numbness on the ARTISS-treated sides of the face. The safety profile of ARTISS was excellent. A total of 19 adverse events (AEs) in 17 subjects were reported. One serious AE occurred, on the side of the face that received SoC (unrelated to ARTISS). Of the 18 non-serious AEs, 1 occurred exclusively on a side of the face treated with ARTISS (unrelated to ARTISS), and 12 occurred exclusively on SoC-receiving sides of the face.
These data suggest that ARTISS is safe and efficacious for use in rhytidectomy. ARTISS may significantly reduce both the volume of drainage postoperatively, and the incidence of hematoma and seroma.