Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage
Condition: Abdominoplasty
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to evaluate the safety and efficacy of the device while reducing the
      amount of drainage from surgical wounds following large flap surgical procedures, in this
      case abdominoplasty, as compared to the standard of care (closure techniques). 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: 
      Background:

      Fluid accumulation in dissected tissue planes has been a longstanding problem following
      surgical procedures. The common use of closed suction drains has been associated with
      infection risk, wound healing complications, additional scarring, and patient discomfort.
      Additionally, seroma formation after drain removal often requires invasive treatment.
      Therapies that can reduce fluid accumulation and decrease the need for drains will have a
      positive impact on surgical practice.

      Objectives:

        -  To establish that the use of TissuGlu® Surgical Adhesive is a safe and effective
           alternative to drains (standard of care) for fluid management following abdominoplasty.

        -  To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative invasive
           treatments, and seroma formation.

        -  To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative subject
           satisfaction and quality of life.

        -  To document the type and duration of adverse events associated with TissuGlu® used
           during an abdominoplasty procedure as an alternative to drains.

      Material and Methods:

      A prospective randomized trial comparing standard wound closure technique with drains in 130
      subjects (control group n=65) to standard wound closure techniques plus TissuGlu® and no
      drains (test group n=65) during Abdominoplasty.

      For subjects randomized into the Test Group, TissuGlu® will be applied to one surface of the
      exposed tissue flap using the custom applicator during a standard abdominoplasty procedure
      followed by normal wound closure (suturing technique) without drain placement. The applicator
      device will deliver an array of drops spaced equidistant apart. The user may then reposition
      the device to the next area and repeat the application process. Each device will dispense
      approximately 5 ml of adhesive. It is expected that one 5 ml device will suffice for the
      average sized subject (400-500 sq cm tissue flap). The TissuGlu® is applied using the
      disposable applicator to the tissue surfaces to be adhered just prior to standard closure.
      The tissue is then approximated, and the wound is closed using standard suturing techniques.
      TissuGlu® will begin to cure upon exposure to moisture in the tissue. The cure process takes
      approximately 30-45 minutes.

      Subjects that are randomized to the Control Group will undergo normal wound closure (suturing
      technique) and placement of two size 12 Blake drains.
    

Intervention name(s): TissuGlu Surgical Adhesive
Intervention type(s): Device
Intervention description(s): TissuGlu Surgical Adhesive to be used prior to closure of the large tissue flap in abdominoplasty cases.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment