Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161980
Status:
COMPLETED
Last Update Posted:
2006-10-23
First Post:
2005-09-08
Brief Title:
Efficacy and Safety of Fibrin Sealant Vapor Heated SolventDetergent Treated FS VH SD for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
A Randomized and Controlled Clinical Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH SD FS VH SD in Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will monitor the safety of FS VH SD and will evaluate whether FS VH SD 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None