Status:
COMPLETED
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
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Breast Cancer
Lumpectomy
Eligibility:
FEMALE
19+ years
Phase:
PHASE3
Brief Summary
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 lympha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2002
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00161980
Start Date
June 1 2001
End Date
December 1 2002
Last Update
October 23 2006
Active Locations (8)
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1
Landeskrankenhaus St. Pölten
Sankt Pölten, Lower Austria, Austria, 3100
2
Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology
Vienna, Austria, 1090
3
Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis
Rennes, France, 35062
4
Ludwig-Maximilians-Universität
Munich, Germany, 80337