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

NCT00161980 | Completed Phase 3

• 1 other identifier: 550002
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 8

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.

Conditions

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

Keywords

Axillary wound; Seroma; Fistulae

Interventions

Fibrin Sealant VH S/D DRUG

Surgical intervention alone without Fibrin Sealant VH S/D application PROCEDURE

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (8)

Landeskrankenhaus St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

Location

Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology

Vienna, 1090, Austria

Location

Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis

Rennes, 35062, France

Location

Ludwig-Maximilians-Universität

Munich, 80337, Germany

Location

Universitätsklinikum Tübingen, Frauenklinik

Tübingen, 72076, Germany

Location

Universitätsklinikum - Frauenklinik

Würzburg, 97080, Germany

Location

S. Luigi - S. Curro, Presidi Ospedalieri Unificati

Catania, 95100, Italy

Location

Istituto Nationale per la Ricerca sul Cancro

Genova, 16132, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Berger, MD

  General Hospital / University Hospital Vienna, Austria

  PRINCIPAL INVESTIGATOR

• Diethelm Wallwiener, MD

  University of Tübingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: June 1, 2001
• Study Completion: December 1, 2002
• Last Updated: October 23, 2006

Record last verified: 2006-10

Locations

DE (3); AU (2); FR (1); IT (2)