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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161980

Enrollment

Unknown

Registered

2005-09-13

Start date

2001-06-30

Completion date

2002-12-31

Last updated

2006-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lumpectomy, Lymphatic Leakage, Mastectomy Plus Axillary Lymph Node Dissection

Keywords

Axillary wound, Seroma, Fistulae

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.

Interventions

DRUGFibrin Sealant VH S/D

PROCEDURESurgical intervention alone without Fibrin Sealant VH S/D application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

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

Countries

Austria, France, Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026