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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00161980 |
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Date of registration:
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08/09/2005 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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June 2001 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00161980 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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Countries of recruitment
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Austria
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France
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Germany
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Italy
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Contacts
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Name:
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Andreas Berger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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General Hospital / University Hospital Vienna, Austria |
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Name:
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Diethelm Wallwiener, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Tübingen, Germany |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Lumpectomy
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Lymphatic Leakage
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Mastectomy Plus Axillary Lymph Node Dissection
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Intervention(s)
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Drug: Fibrin Sealant VH S/D
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Procedure: Surgical intervention alone without Fibrin Sealant VH S/D application
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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