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.
About ARTISS
ARTISS [Fibrin Sealant (Human)], Vapor Heated, Solvent
Detergent Treated, (ARTISS) is a two-component fibrin sealant made
from pooled human plasma. When combined, the two components, Sealer
Protein (Human) and Thrombin (Human), mimic the final stage of the
blood coagulation cascade. ARTISS is currently 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. ARTISS is not indicated for hemostasis.
Important Risk Information
For Topical Use Only. Do not inject ARTISS directly into
blood vessels. Intravascular application of ARTISS may result in
life-threatening thromboembolic events.
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
About Baxter
Baxter International Inc., through its subsidiaries,
develops, manufactures and markets products that save and sustain
the lives of people with hemophilia, immune disorders, infectious
diseases, kidney disease, trauma, and other chronic and acute
medical conditions. As a global, diversified healthcare
company, Baxter applies a unique combination of expertise in
medical devices, pharmaceuticals and biotechnology to create
products that advance patient care worldwide.
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