Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 8:02 PM
Study NCT ID:
NCT01791504
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2012-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive
Sponsor:
Cohera Medical, Inc.
Organization:
Study Overview
Official Title:
A Clinical Investigation for a Randomized Study Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques Plus TissuGlu® and No Drains (Test) During Abdominoplasty
Status:
COMPLETED
Status Verified Date:
2013-12
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 this study is to determine if TissuGlu® Surgical Adhesive is safe and effective alternative to drains(standard of care) for fluid management following abdominoplasty. It is hypothesized that the use of the Cohera device will facilitate reduction or closure of dead space when applied to planar surfaces created during an abdominoplasty procedure.
Detailed Description:
The Cohera TissuGlu® study is a pivotal, prospective clinical investigation for a randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques plus TissuGlu® and no drains (test) during abdominoplasty. TissuGlu® will be applied to the test group prior to standard closure of the abdominal flap thereby eliminating the deadspace between the fascia and the flap. No closed suction drains will be inserted in the test group. The control group will receive closed suction drains per the standard of care. It is hypothesized that the elimination of deadspace in the wound in the test group will prevent post-surgical fluid from developing and causing seroma and that the number of invasive treatments related to aspirations in the test group will not be inferior to the management and removal of drains and aspirations for seroma in the control group. The study will be conducted with 130 patients (65 test, 65 control) at up to 5 sites.
Study Oversight
Has Oversight DMC:
False
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?: