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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

NCT ID: NCT00161980

Last Updated: 2006-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2002-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Lumpectomy Mastectomy Plus Axillary Lymph Node Dissection Lymphatic Leakage

Keywords

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Axillary wound Seroma Fistulae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Fibrin Sealant VH S/D

Intervention Type DRUG

Surgical intervention alone without Fibrin Sealant VH S/D application

Intervention Type PROCEDURE

Eligibility 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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Andreas Berger, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital / University Hospital Vienna, Austria

Diethelm Wallwiener, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tübingen, Germany

Locations

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Landeskrankenhaus St. Pölten

Sankt Pölten, Lower Austria, Austria

Site Status

Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology

Vienna, , Austria

Site Status

Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis

Rennes, , France

Site Status

Ludwig-Maximilians-Universität

Munich, , Germany

Site Status

Universitätsklinikum Tübingen, Frauenklinik

Tübingen, , Germany

Site Status

Universitätsklinikum - Frauenklinik

Würzburg, , Germany

Site Status

S. Luigi - S. Curro, Presidi Ospedalieri Unificati

Catania, , Italy

Site Status

Istituto Nationale per la Ricerca sul Cancro

Genova, , Italy

Site Status

Countries

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Austria France Germany Italy

Other Identifiers

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550002

Identifier Type: -

Identifier Source: org_study_id