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

October 20, 2006 updated by: Baxter Healthcare Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology
    • Niederösterreich
      • St. Pölten, Niederösterreich, Austria, 3100
        • Landeskrankenhaus St. Pölten
  • France
      • Rennes, France, 35062
        • Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis
  • Germany
      • Munich, Germany, 80337
        • Ludwig-Maximilians-Universität
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen, Frauenklinik
      • Würzburg, Germany, 97080
        • Universitätsklinikum - Frauenklinik
  • Italy
      • Catania, Italy, 95100
        • S. Luigi - S. Curro, Presidi Ospedalieri Unificati
      • Genova, Italy, 16132
        • Istituto Nationale per la Ricerca sul Cancro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 13, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

October 23, 2006

Last Update Submitted That Met QC Criteria

October 20, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 550002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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