ClinicalTrials.Veeva

Menu

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

Baxter logo

Baxter

Status and phase

Completed
Phase 3

Conditions

Mastectomy Plus Axillary Lymph Node Dissection
Breast Cancer
Lumpectomy
Lymphatic Leakage

Treatments

Drug: Fibrin Sealant VH S/D
Procedure: Surgical intervention alone without Fibrin Sealant VH S/D application

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Sex

Female

Ages

19+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

8

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems