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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Inflammation Lumpectomy Lymphatic Leakage Mastectomy Plus Axillary Lymph Node Dissection Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Seroma Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Landeskrankenhaus St. Pölten, Sankt Pölten, Lower Austria, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibrin Sealant VH S/D

Drug

Surgical intervention alone without Fibrin Sealant VH S/D application

Procedure

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study 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

Important dates

Study start: 2001
Study completion: 2002
First posted: Sep 13, 2005
Registry last updated: Oct 23, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed