Evaluation of Cohera TissuGlu in the Management of Wound Drainage Following Abdominoplasty - Full Text View

Purpose

A blinded, prospective, randomized trial in 40 abdominoplasty cases at three sites to study the safety and the preliminary efficacy of TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures.

Condition	Intervention	Phase
Abdominoplasty	Device: Cohera TissuGlu Surgical Adhesive Procedure: Control- Standard of care	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Clinical Evaluation of the Cohera TissuGlu Device in the Management of Wound Drainage Following Abdominoplasty

Further study details as provided by Cohera Medical, Inc.:

Primary Outcome Measures:

• 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• 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. ] [ Designated as safety issue: No ]
• Number of wound complications, seroma formation, wound dehiscence, infection, skin necrosis, hematoma [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ] [ Designated as safety issue: No ]
• Cumulative drainage volume for each patient [ Time Frame: Assessed at time of drain removal- Average 2-5 days post surgery. ] [ Designated as safety issue: No ]
• Number of additional physician or clinic visits [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ] [ Designated as safety issue: No ]
• Number/type of additional procedures due to complications [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ] [ Designated as safety issue: No ]
• Evaluation of the delivery method/delivery device (Surgeon questionnaire) [ Time Frame: Assessed at time of surgery/use of the device (Day 0) ] [ Designated as safety issue: No ]
Questionnaire completed by the surgeon after the surgery rating ergonomics, visibility, ability to deliver the adhesive and overall satisfaction with the delivery method.

Enrollment:	40
Study Start Date:	December 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Be at least 20 years of age;
Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;
Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure, Surgeon must use electrocautery in the procedure;
Be willing to follow instructions for incision care, comply with schedule for wound drainage volume measurements, and follow guidelines related to resumption of daily activities;
Agree to return for all follow-up evaluations specified in this protocol;
Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in this study is complete; and
Sign the informed consent.

Exclusion Criteria:

Anesthesia Risk judged to be higher than ASA2
Previous Abdominoplasty
Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
Any condition involving compromised vascular flow to the abdominal wall tissue. Prior abdominal scars, especially subcostal scars, will be a relative contraindication and judged on a case by case basis by the surgeon investigator.
Any condition known to effect wound healing, such as collagen vascular disease
Current active tobacco use, including smokeless (chewing) tobacco
Obesity, as defined by BMI >30
Known blood clotting disorder
Current diagnosis of diabetes
Be receiving antibiotic therapy for pre-existing condition or infection
Have known personal or family history of keloid formation or hypertrophy
Undergoing concurrent adjacent or congruent Liposuction procedures
Concurrent use of fibrin sealants or other internal wound care devices
Be currently taking systemic steroids or immunosuppressive agents
Concurrent hernia repair greater than 6 cm and/or requiring the use of mesh
Mini abdominoplasty (Abdominoplasty without umbilical transposition)
Have known or suspected allergy or sensitivity to any test materials or reagents
Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Pregnancy (30 days post-op)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331798

Locations

Germany
University of Bonn
Bonn, Germany
Rosenpark Klinik
Darmstadt, Germany
Erich-Lexer-Klinik
Freiburg, Germany

Sponsors and Collaborators

Cohera Medical, Inc.

More Information

No publications provided

Responsible Party:	Contact: Chad Coberly, VP Clinical Affairs, Cohera Medical Inc.
ClinicalTrials.gov Identifier:	NCT01331798 History of Changes
Other Study ID Numbers:	PRO-100-0002
Study First Received:	April 6, 2011
Last Updated:	April 7, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Cohera Medical, Inc.:

Abdominoplasty

ClinicalTrials.gov processed this record on May 22, 2013