Deerfield, Ill. — Baxter International, based here, has announced that its human fibrin sealant Artiss can reduce drainage volumes at 24 hours after rhytidectomy surgery.
The company released results of a phase 3 study evaluating the safety and efficacy of Artiss, indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adults and children ages 1 year and older.
Researchers compared the total drainage volume for each side of the face of 75 patients 24 hours postsurgery. Drainage volume was collected in a standardized manner 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.
The study found that adjunctive Artiss use reduced total drainage volumes by the following amounts: a mean ± standard deviation volume of 7.7 ± 7.4 mL drained after 24 hours on the Artiss-treated sides, compared with 20.0 ± 11.3 mL on the standard-of-care-only sides. Pressure dressings were not permitted in the study.
Investigators also found that seven hematoma/seroma events occurred in a total of five patients on the Artiss-treated sides of the face, and eight events occurred in a total of eight patients on the standard-of-care sides. The study also noted a total of 11 facial adverse events in six patients on Artiss-treated face sides, including one serious wound abscess in which methicillin-resistant Staphylococcus aureus (MRSA) occurred. A total of 12 facial adverse events occurred in 11 patients on the standard-of-care-treated sides of the face.
The Baxter statement notes that the study results require review and validation by the Food and Drug Administration.