Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-26 @ 9:21 AM
Study NCT ID:
NCT01527357
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2012-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Fibrocaps™ in Surgical Bleeding
Sponsor:
Mallinckrodt
Organization:
Study Overview
Official Title:
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
Status:
COMPLETED
Status Verified Date:
2016-07
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:
FINISH-3
Brief Summary:
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.
The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: