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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2006-10-23

No results posted yet for this study

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

DRUG

Fibrin Sealant VH S/D

PROCEDURE

Surgical intervention alone without Fibrin Sealant VH S/D application

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Andreas Berger, MD · General Hospital / University Hospital Vienna, Austria

  • Diethelm Wallwiener, MD · University of Tübingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Completion
2002-12-31

Countries

  • Austria
  • France
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161980 on ClinicalTrials.gov