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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


Phase 3
19 Years
N/A
Not Enrolling
Female
Breast Cancer, Lumpectomy, Mastectomy Plus Axillary Lymph Node Dissection, Lymphatic Leakage

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Principal Investigator

Andreas Berger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

General Hospital / University Hospital Vienna, Austria

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

550002

NCT ID:

NCT00161980

Start Date:

June 2001

Completion Date:

December 2002

Related Keywords:

  • Breast Cancer
  • Lumpectomy
  • Mastectomy Plus Axillary Lymph Node Dissection
  • Lymphatic Leakage
  • Axillary wound
  • Seroma
  • Fistulae
  • Breast Neoplasms

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