DEERFIELD, Ill., April 10, 2011 - 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.
Important Risk Information
Do not use ARTISS in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substance or excipients.
Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of ARTISS. Symptoms associated with allergic anaphylactic reactions include: flush, urticaria, pruritus, nausea, drop in blood pressure, tachycardia or bradycardia, dyspnea, severe hypotension and anaphylactic shock. Such reactions may also occur in patients receiving ARTISS for the first time.
Discontinue administration of ARTISS in the event of hypersensitivity reactions.
Apply as a thin layer. Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.
Air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants. This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface.
When applying ARTISS using a spray device, be sure to use the pressure within the pressure range recommended by the spray device manufacturer.
Exposure to solutions containing alcohol, iodine or heavy metals may cause ARTISS to be denatured. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of ARTISS and made as dry as possible.
ARTISS is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Adverse reactions occurring in greater than 1% of patients treated with ARTISS were skin graft failure (5 events of 138 patients treated) and pruritus (2 events of 138 patients treated).For full prescribing information, please visit: http://www.baxter.com/downloads/healthcare_professionals/products/ARTISS_PI.pdf