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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

Sponsor
Baxter Healthcare Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00161980
Collaborator
(none)
8
Locations
18
Duration (Months)

Study Details

Study Description

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
  • Drug: Fibrin Sealant VH S/D
  • Procedure: Surgical intervention alone without Fibrin Sealant VH S/D application
 Phase 3

Study Design

Study Type:
Interventional
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 :
Jun 1, 2001
Study Completion Date :
Dec 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Landeskrankenhaus St. Pölten St. Pölten Niederösterreich 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
    5 Universitätsklinikum Tübingen, Frauenklinik Tübingen Germany 72076
    6 Universitätsklinikum - Frauenklinik Würzburg Germany 97080
    7 S. Luigi - S. Curro, Presidi Ospedalieri Unificati Catania Italy 95100
    8 Istituto Nationale per la Ricerca sul Cancro Genova Italy 16132

    Sponsors and Collaborators

    • Baxter Healthcare Corporation

    Investigators

    • Principal Investigator: Andreas Berger, MD, General Hospital / University Hospital Vienna, Austria
    • Principal Investigator: Diethelm Wallwiener, MD, University of Tübingen, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00161980
    Other Study ID Numbers:
    • 550002
    First Posted:
    Sep 13, 2005
    Last Update Posted:
    Oct 23, 2006
    Last Verified:
    Oct 1, 2006
    Keywords provided by , ,
    Axillary wound
    Seroma
    Fistulae
    Additional relevant MeSH terms:
    Fibrin Tissue Adhesive

    Study Results

    No Results Posted as of Oct 23, 2006