Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT01112735
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2010-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty
Sponsor:
Baxter Healthcare Corporation
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of ARTISS (FS VH S/D 4 S-apr) for Flap Adherence in Subjects Undergoing Abdominoplasty
Status:
COMPLETED
Status Verified Date:
2018-06
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:
The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: