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
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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.
Condition or disease
Breast CancerLumpectomyMastectomy Plus Axillary Lymph Node DissectionLymphatic Leakage
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Layout table for eligibility information
Ages Eligible for Study:
19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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