Baxter International Inc. (NYSE: BAX) announced today the results of a phase III study evaluating the safety and efficacy of ARTISS [Fibrin Sealant (Human)] in 75 patients. The study compared the total drainage volume for each side of the face at 24 hours post rhytidectomy, or face lift surgery. This data was presented at the American Association of Plastic Surgeons (AAPS) 90th Annual Meeting on April 10 in Boca Raton, Fla.
"This study suggests that ARTISS can reduce drainage volumes at 24 hours after rhytidectomy surgery," said Steve Zvi Abrams, M.D., medical director for Baxter's BioScience business. "Within the reconstructive and cosmetic plastic surgeon community, there is considerable interest in products that may be able to aid in tissue adherence."
ARTISS is a fibrin sealant indicated to adhere autologous skin grafts to surgically prepared wound beds, resulting from burns in adult and pediatric populations greater than or equal to one year of age. The product is being studied to determine if it can support tissue adherence in patients undergoing facelift surgery.
In standard of care facelift surgery, sutures are used to close the flap of skin at its edge, which often leaves a space underneath. In patients undergoing facelift surgery, post-operative drainage volume and the incidence of hematoma or seroma (accumulation of blood or fluid under the skin, respectively) are important post-operative measures in assessing recovery. In this study, ARTISS was applied with sutures with the goal of improving flap adherence as indicated by reduced post operative drainage.
The multi-center, prospective, randomized phase III clinical study was performed in 75 patients. The study compared the total drainage volume, collected in a standardized manner, for each side of the face at 24 hours post-surgery using a split-face study design, in which one side of the patient's face was sutured per standard of care while the other also received the ARTISS fibrin sealant.
Adjunctive ARTISS use reduced total drainage volumes at 24 hours immediately following rhytidectomy compared with standard of care (a mean ± standard deviation volume of 7.7 ± 7.4 mL drained after 24 hours 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 standard of care alone) without the use of pressure dressings, which were not permitted in the study. Investigators recorded the presence of hematoma/seroma throughout the follow-up period. Seven hematoma/seroma events occurred in a total of 5 patients on the ARTISS-treated sides of the face, and 8 events occurred in a total of 8 patients on the standard of care receiving sides of the face. The results of previous research suggest that post-operative drainage can be a surrogate marker of tissue adherence and elimination of "dead space" between the wound bed and tissue flap.
On sides of the face treated with ARTISS, a total of 11 facial adverse events (AEs) in 6 patients were reported. One serious AE, wound abscess with methicillin-resistant Staphylococcus aureus (MRSA), occurred. For the standard of care treated sides of the face, a total of 12 facial AEs occurred in 11 patients.
These results require review and validation by the United States Food and Drug Administration (FDA). Baxter currently has an efficacy supplement application pending with the FDA for an extension of indication for use in facelift surgery.