Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive

Cohera Medical

Status and phase

Completed

Phase 3

Phase 2

Conditions

Disorder of Skin and/or Subcutaneous Tissue of Trunk

Treatments

Device: TissuGlu Surgical Adhesive

Study type

Interventional

Funder types

Industry

Identifiers

NCT01791504

PRO-100-0085

Details and patient eligibility

About

The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and effective alternative to drains(standard of care) for fluid management following abdominoplasty. 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.

Full description

The Cohera TissuGlu® study is a pivotal, prospective clinical investigation for a randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques plus TissuGlu® and no drains (test) during abdominoplasty. TissuGlu® will be applied to the test group prior to standard closure of the abdominal flap thereby eliminating the deadspace between the fascia and the flap. No closed suction drains will be inserted in the test group. The control group will receive closed suction drains per the standard of care. It is hypothesized that the elimination of deadspace in the wound in the test group will prevent post-surgical fluid from developing and causing seroma and that the number of invasive treatments related to aspirations in the test group will not be inferior to the management and removal of drains and aspirations for seroma in the control group. The study will be conducted with 130 patients (65 test, 65 control) at up to 5 sites.

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, ≥ 18 years of age
Provide signed and dated informed consent form
Willing to comply with all study procedures, schedules and be available for the follow-up evaluations for the duration of the study
Willing to follow instructions for incision and drain care, and follow guidelines related to resumption of daily activities
Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in the study is complete
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
Requiring at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty
≤ ASA2 - American Society of Anesthesiologists Physical Classification System (2=subject with mild systemic disease)
Have a Body Mass Index (BMI) ≤ 28

Exclusion criteria

Pregnancy or lactation
Previous abdominoplasty
Prior bariatric or weight loss surgery
Lost ≥ 15% of maximum lifetime bodyweight (excluding pregnancy weight gain)
Known medical condition that results in compromised blood supply to tissues
Have known or suspected allergy or sensitivity to any test materials or reagents
Have severe co-morbid conditions (e.g., heart disease)
Are currently a smoker or have smoked within 30 days of prescreening as determined by nicotine test
Any condition known to effect wound healing, such as collagen vascular disease
Be known to have a blood clotting disorder and/or be willing to discontinue anti-coagulation therapy including aspirin
Diagnosis of diabetes with current medical treatment
Receiving antibiotic therapy for pre-existing condition or infection
Have known personal or family history of keloid formation or hypertrophic scarring
Currently taking systemic steroids or immunosuppressive agents
Undergoing concurrent adjacent or congruent Liposuction agents
Use of pain pumps after the abdominoplasty procedure
Concurrent use of fibrin sealants or other internal wound care devices
Concurrent hernia repair greater than 6 cm and/or requiring the use of mesh
Mini abdominoplasty (abdominoplasty without umbilical transposition)
Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study