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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Fibrin Sealant VH S/D
PROCEDURE	Surgical intervention alone without Fibrin Sealant VH S/D application

Timeline

• Start date: 2001-06-01
• Completion: 2002-12-01
• First posted: 2005-09-13
• Last updated: 2006-10-23

Locations

8 sites across 4 countries: Austria, France, Germany, Italy