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

NCT01791504 | Completed Phase 2

• 1 other identifier: PRO-100-0085
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disorder of Skin and/or Subcutaneous Tissue of Trunk

Keywords

Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Number of Post-Operative Invasive Treatments

  Number of Post-Operative Invasive Treatments, where Invasive Treatment is defined as one of the following events: * Removal of an in-dwelling drain; * Needle aspiration to remove fluid from a clinically-diagnosed palpable seroma; * Invasive action to the drain or drain wound such as repositioning or re-attaching the drain retention sutures; * Reinsertion of a drain

  90 Days

Secondary Outcomes (1)

• Secondary Outcome Measures

  90 Day

Study Arms (2)

TissuGlu Surgical Adhesive

EXPERIMENTAL

Standard wound closure techniques plus TissuGlu and no drains.

Device: TissuGlu Surgical Adhesive

Control - Standard of Care

NO INTERVENTION

Standard wound closure techniques with drains.

Interventions

TissuGlu Surgical Adhesive DEVICE

Standard Wound Closure Techniques Plus TissuGlu and no drains.

TissuGlu Surgical Adhesive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cohera Medical, Inc.: lead

Study Sites (1)

The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa

Huntersville, North Carolina, 28078, United States

Location

Study Officials

• Joseph Hunstad, MD

  The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: February 15, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 5, 2013

Record last verified: 2013-12

Locations

US (1)