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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161980
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : October 23, 2006
Sponsor:
Information provided by:
Baxter Healthcare Corporation

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 lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph node dissection with two separate incisions.

Condition or disease Intervention/treatment Phase
Breast Cancer Lumpectomy Mastectomy Plus Axillary Lymph Node Dissection Lymphatic Leakage Drug: Fibrin Sealant VH S/D Procedure: Surgical intervention alone without Fibrin Sealant VH S/D application Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2001
Study Completion Date : December 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161980


Locations
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Austria
Landeskrankenhaus St. Pölten
St. Pölten, Niederösterreich, Austria, 3100
Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology
Vienna, Austria, 1090
France
Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis
Rennes, France, 35062
Germany
Ludwig-Maximilians-Universität
Munich, Germany, 80337
Universitätsklinikum Tübingen, Frauenklinik
Tübingen, Germany, 72076
Universitätsklinikum - Frauenklinik
Würzburg, Germany, 97080
Italy
S. Luigi - S. Curro, Presidi Ospedalieri Unificati
Catania, Italy, 95100
Istituto Nationale per la Ricerca sul Cancro
Genova, Italy, 16132
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Andreas Berger, MD General Hospital / University Hospital Vienna, Austria
Principal Investigator: Diethelm Wallwiener, MD University of Tübingen, Germany
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ClinicalTrials.gov Identifier: NCT00161980    
Other Study ID Numbers: 550002
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: October 23, 2006
Last Verified: October 2006
Keywords provided by Baxter Healthcare Corporation:
Axillary wound
Seroma
Fistulae
Additional relevant MeSH terms:
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Fibrin Tissue Adhesive
Hemostatics
Coagulants