Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157131
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2005-09-08
Brief Title:
Safety and Efficacy Study of FS 4 IU VH SD Fibrin Sealant With 4IUmL Thrombin Vapor Heated SolventDetergent Treated to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
A Study To Evaluate the Safety and Efficacy of Fibrin Sealant With 4IUmL Thrombin Vapor Heated Solvent Detergent Treated FS 4IU VH SD to Adhere Tissues and Improve Wound Healing
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH SD is equivalent or superior to the current standard of care staples The primary endpoint is achievement of complete 100 wound closure within 28 days
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