Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Controlled, Single-blind, Multicenter Clinical Trial Evaluating the Safety and Efficacy of the Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage as Compared to the Standard of Care Closure Techniques Following Abdominoplasty|
- Time to reach drain removal criteria. [ Time Frame: Measured until drains are removed, up to 30 days post-op. ] [ Designated as safety issue: No ]Primary efficacy endpoint is time (days) to reach drain removal criteria of less than 30ml per 24hr period.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: TissuGlu Surgical Adhesive
Experimental Arm: standard of care plus TissuGlu Surgical Adhesive and no drains
Device: TissuGlu Surgical Adhesive
TissuGlu Surgical Adhesive to be used prior to closure of the large tissue flap in abdominoplasty cases.
No Intervention: Control- Standard of Care
Control Arm: standard of care plus drains and no TissuGlu Surgical Adhesive
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.
- 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.