A Randomized and Controlled Clinical Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D (FS VH S/D) in Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites
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