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

Baxter

Status and phase

Completed

Phase 3

Conditions

Mastectomy Plus Axillary Lymph Node Dissection

Breast Cancer

Lumpectomy

Lymphatic Leakage

Treatments

Drug: Fibrin Sealant VH S/D

Procedure: Surgical intervention alone without Fibrin Sealant VH S/D application

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161980

550002

Details and patient eligibility

About

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.

Sex

Female

Ages

19+ years old

Volunteers

No Healthy Volunteers

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