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

Primary Purpose

Disorder of Skin and/or Subcutaneous Tissue of Trunk

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TissuGlu Surgical Adhesive
Sponsored by
Cohera Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Skin and/or Subcutaneous Tissue of Trunk focused on measuring Abdominoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TissuGlu Surgical Adhesive

Control - Standard of Care

Arm Description

Standard wound closure techniques plus TissuGlu and no drains.

Standard wound closure techniques with drains.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary Outcome Measures
• Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)

Full Information

First Posted
December 6, 2012
Last Updated
December 3, 2013
Sponsor
Cohera Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01791504
Brief Title
Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive
Official Title
A Clinical Investigation for a Randomized Study Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques Plus TissuGlu® and No Drains (Test) During Abdominoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cohera Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Skin and/or Subcutaneous Tissue of Trunk
Keywords
Abdominoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TissuGlu Surgical Adhesive
Arm Type
Experimental
Arm Description
Standard wound closure techniques plus TissuGlu and no drains.
Arm Title
Control - Standard of Care
Arm Type
No Intervention
Arm Description
Standard wound closure techniques with drains.
Intervention Type
Device
Intervention Name(s)
TissuGlu Surgical Adhesive
Intervention Description
Standard Wound Closure Techniques Plus TissuGlu and no drains.
Primary Outcome Measure Information:
Title
Number of Post-Operative Invasive Treatments
Description
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
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Secondary Outcome Measures
Description
• Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)
Time Frame
90 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Hunstad, MD
Organizational Affiliation
The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States

12. IPD Sharing Statement

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

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