Clinical trial NCT00161980: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lumpectomy
Mastectomy Plus Axillary Lymph Node Dissection
Lymphatic Leakage
Keywords: Axillary wound
Seroma
Fistulae
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Pölten
country: Austria
facility: Landeskrankenhaus St. Pölten
state: Niederösterreich
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology
city: Rennes
country: France
facility: Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universität
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Frauenklinik
city: Würzburg
country: Germany
facility: Universitätsklinikum - Frauenklinik
city: Catania
country: Italy
facility: S. Luigi - S. Curro, Presidi Ospedalieri Unificati
city: Genova
country: Italy
facility: Istituto Nationale per la Ricerca sul Cancro
Study officials:
affiliation: General Hospital / University Hospital Vienna, Austria
name: Andreas Berger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tübingen, Germany
name: Diethelm Wallwiener, MD
role: PRINCIPAL_INVESTIGATOR
References: