Evaluation of Cohera TissuGlu in the Management of Wound Drainage Following Abdominoplasty
|Abdominoplasty||Device: Cohera TissuGlu Surgical Adhesive Procedure: Control- Standard of care||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Clinical Evaluation of the Cohera TissuGlu Device in the Management of Wound Drainage Following Abdominoplasty|
- • Safety data will be gathered with respect to the number, timing, severity, duration and resolution of device and non-device related adverse events occurring among study subjects. [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ]
- • Time to drain removal based upon a drain removal criteria of <30ml of fluid accumulation in a twenty four (24) hour period (Scevola et al, 2002; Momeni et al, 2008). [ Time Frame: Assessed at time of drain removal- Average 2 to 5 days post surgery. ]
- • Number of wound complications, seroma formation, wound dehiscence, infection, skin necrosis, hematoma [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ]
- • Cumulative drainage volume for each patient [ Time Frame: Assessed at time of drain removal- Average 2-5 days post surgery. ]
- • Number of additional physician or clinic visits [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ]
- • Number/type of additional procedures due to complications [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ]
- • Evaluation of the delivery method/delivery device (Surgeon questionnaire) [ Time Frame: Assessed at time of surgery/use of the device (Day 0) ]Questionnaire completed by the surgeon after the surgery rating ergonomics, visibility, ability to deliver the adhesive and overall satisfaction with the delivery method.
|Study Start Date:||December 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Test: TissuGlu Adhesive
Patients received the TissuGlu Adhesive Treatment
Device: Cohera TissuGlu Surgical Adhesive
TissuGlu device used prior to closing of the flap in the abdominoplasty procedure.
Active Comparator: Control
Control Arm received no TissuGlu- Standard of Care received.
Procedure: Control- Standard of care
Control Arm- no TissuGlu device used. Standard abdominoplasty procedure followed.
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.
Objective: To study the safety and the preliminary efficacy of a TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures.
Material & Methods: A blinded prospective randomized trial compared drain fluid output (volume) and complication profile in 40 subjects undergoing abdominoplasty with (n=20) or without (n=20) the use of a urethane based adhesive. The TissuGlu® adhesive, which required no mixing or preparation, was administered to the abdominal wall using a custom drop tip applicator prior to closure of the abdominoplasty flap. Two Blake® drains connected to J-VAC suction reservoirs were placed in the wound.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331798
|University of Bonn|