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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161980
• Other study ID #: 550002
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: October 20, 2006
• Start date: June 2001
• Est. completion date: December 2002

Study information

• Verified date: October 2006
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Lumpectomy
• Lymphatic Leakage
• Mastectomy Plus Axillary Lymph Node Dissection

Intervention

Drug:
• Fibrin Sealant VH S/D

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,