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

Cohera Medical

Status and phase

Completed

Phase 2

Phase 1

Conditions

Abdominoplasty

Treatments

Device: Cohera TissuGlu Surgical Adhesive

Procedure: Control- Standard of care

Study type

Interventional

Funder types

Industry

Identifiers

NCT01331798

PRO-100-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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)