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

Phase 3

Completed

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

• Registration Number: NCT00161980
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Study Completion: 2002-12
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-13
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-20
• Last Update Posted: 2006-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (8)

Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis; 🇫🇷 Rennes, France

S. Luigi - S. Curro, Presidi Ospedalieri Unificati; 🇮🇹 Catania, Italy

Ludwig-Maximilians-Universität; 🇩🇪 Munich, Germany

Universitätsklinikum Tübingen, Frauenklinik; 🇩🇪 Tübingen, Germany

Istituto Nationale per la Ricerca sul Cancro; 🇮🇹 Genova, Italy

Universitätsklinikum - Frauenklinik; 🇩🇪 Würzburg, Germany

Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology; 🇦🇹 Vienna, Austria

Landeskrankenhaus St. Pölten; 🇦🇹 St. Pölten, Niederösterreich, Austria