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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Standard Wound Closure Techniques Plus TissuGlu and no drains.
The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa
Huntersville, North Carolina, United States
Number of Post-Operative Invasive Treatments
Number of Post-Operative Invasive Treatments, where Invasive Treatment is defined as one of the following events: * Removal of an in-dwelling drain; * Needle aspiration to remove fluid from a clinically-diagnosed palpable seroma; * Invasive action to the drain or drain wound such as repositioning or re-attaching the drain retention sutures; * Reinsertion of a drain
Time frame: 90 Days
Secondary Outcome Measures
• Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)
Time frame: 90 Day
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