Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites
This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is
 superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing
 the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph
 node dissection with two separate incisions.
Inclusion Criteria:

 -  Written informed consent has been obtained from the subject prior to FS VH S/D
 administration

 -  Female subjects >= 19 years of age

 -  Subjects with breast cancer scheduled to undergo lumpectomy of the breast and level I
 and II axillary lymphadenectomy with two separate incisions

 Exclusion Criteria:

 -  Subjects with known hypersensitivity to aprotinin or other components of the product

 -  Subjects with immunodeficiency

 -  Subjects with increased red cell production (e.g., in hemolytic anemia)

 -  Subjects with coagulation disorders shown by exceeding the normal range of any of
 following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT),
 fibrinogen level, or thrombocytes.

 -  Subjects having previously had axillary surgery

 -  Subjects having undergone irradiation therapy to the axillary tissue

 -  Subjects having ever received chemotherapy before the surgery