Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive
NCT01791504 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2013-12-05
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.
Conditions
- Disorder of Skin and/or Subcutaneous Tissue of Trunk
Interventions
- DEVICE
-
TissuGlu Surgical Adhesive
Standard Wound Closure Techniques Plus TissuGlu and no drains.
Sponsors & Collaborators
-
Cohera Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Joseph Hunstad, MD · The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2013-09-30
- Completion
- 2013-11-30
Countries
- United States
Study Locations
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