Clinical trial · Interventional
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
NCT00161980CI-TRIAL-00000487completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lumpectomy | — | UNRESOLVED | — |
| Lymphatic Leakage | — | UNRESOLVED | — |
| Mastectomy Plus Axillary Lymph Node Dissection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fibrin Sealant VH S/D | Drug | — | UNRESOLVED |
| Surgical intervention alone without Fibrin Sealant VH S/D application | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.