Evaluation of Cohera TissuGlu in the Management of Wound Drainage Following Abdominoplasty

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Abdominoplasty	Device: Cohera TissuGlu Surgical Adhesive; Procedure: Control- Standard of care	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Clinical Evaluation of the Cohera TissuGlu Device in the Management of Wound Drainage Following Abdominoplasty
Study Start Date :	December 2009
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	May 2010

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. • 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 ]

Secondary Outcome Measures :

1. • 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. ]
2. • Number of wound complications, seroma formation, wound dehiscence, infection, skin necrosis, hematoma [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ]
3. • Cumulative drainage volume for each patient [ Time Frame: Assessed at time of drain removal- Average 2-5 days post surgery. ]
4. • Number of additional physician or clinic visits [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ]
5. • Number/type of additional procedures due to complications [ Time Frame: Discharge, 14, 30, 60, 90 Day follow-up ]
6. • 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.

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

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

Sponsors and Collaborators

Cohera Medical, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	April 8, 2011
Last Update Posted:	April 8, 2011
Last Verified:	April 2011

Keywords provided by Cohera Medical, Inc.:

Abdominoplasty