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Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01716013
Recruitment Status : Completed
First Posted : October 29, 2012
Results First Posted : November 18, 2016
Last Update Posted : January 9, 2017
Information provided by (Responsible Party):
OptMed, Inc.

Brief Summary:

To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in terms of cosmesis (appearance) of the repaired wound when these devices are used for closure of surgical and traumatic wounds .

To demonstrate safety of BondEase™.

Condition or disease Intervention/treatment Phase
Traumatic Lacerations or Surgical Incisions Device: BondEase Procedure: CWCD Not Applicable

Detailed Description:

This is a two-phase, multi-center, prospective, randomized, parallel-group study, in which a total of 153 subjects (102 in the BondEase™ group and 51 in the CWCD group) with traumatic lacerations and incisions will be enrolled. Overall, eligible subjects will be randomized in a pre-defined 2:1 ratio to BondEase™ skin adhesive or CWCD.

In Part 1 of the study 30 subjects will be randomized in a 2:1 ratio (BondEase™ : CWCD). This part of the study is designed to assess the feasibility and validate use of the device. Pediatric subjects younger than age 18 will not be included in this part of the trial. The results from these 30 subjects will be compiled and submitted to FDA for review and approval prior to proceeding with Part 2. Part 2 of the study will only be initiated after FDA indicates it is acceptable to begin. In Part 2 of the study a total of 123 subjects will be randomized, of which 82 subjects will be randomized to the BondEase™ group and 41 subjects to the CWCD group. This will result in 102 subjects in the BondEase™ group and 51 subjects in the CWCD group across the both parts of the trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Open-label, Randomized Study of the Safety and Efficacy of BondEase™ Topical Skin Adhesive for the Closure of Traumatic Lacerations and Surgical Incisions
Study Start Date : September 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BondEase
Topical Skin Adhesive
Device: BondEase
topical skin adhesive

Active Comparator: CWCD
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
Procedure: CWCD
traditional closure methods of sutures, staples or adhesive strips

Primary Outcome Measures :
  1. 100% Wound Apposition at 10 Days [ Time Frame: 10 days ]
    Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.

Secondary Outcome Measures :
  1. Optimal Cosmetic Outcome at 28 Days (Score of 6) [ Time Frame: 28 days ]

    Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.

    One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:

    • Stepoff of borders (edges not on the same plane)
    • Contour irregularities (wrinkled skin near wound)
    • Margin separation (gap between sides)
    • Edge inversion (wound not properly everted)
    • Excessive distortion (swelling or edema or infection)
    • Poor overall appearance.

    The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal.

  2. ≥ 50% Wound Apposition at 10 Days [ Time Frame: 10 days ]
    Incidence of wounds ≥50% apposed (10 ± 3 days)

Other Outcome Measures:
  1. Wound Dehiscence Requiring Treatment [ Time Frame: 28 Days and 90 days ]
    Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female subjects at least 1 year of age (for Part 2 only) or at least 18 years of age (for both Part 1 and Part 2).
  2. Has a wound requiring surgical repair, where the use of a tissue adhesive is appropriate
  3. Is in good general health
  4. Subject or the guardian understands and is willing to sign informed consent prior to study entry and agrees to be available for the Day 10, Day 28, and Day 90 (Part 1/pilot phase only) follow-up visits

Exclusion Criteria:

  1. Significant or multiple traumas
  2. Known peripheral vascular disease
  3. Known diabetes mellitus type 1 or type 2
  4. Known blood clotting disorder
  5. Patient or family history of keloid formation or hypertrophy
  6. Known HIV seropositivity or is immunocompromised
  7. Been treated with an investigational drug or medical device in the past 30 days
  8. A hypersensitivity or contraindication to any of the components of BondEase™
  9. Known pre-operative systemic or local infection
  10. Any other diseases or conditions which might interfere with the wound healing process
  11. The wound to be treated with the test device may not have any of the following characteristics:

    • A "burst" or stellate laceration
    • Heavily contaminated (Contaminated Wound: wounds that are grossly contaminated with foreign material requiring extensive cleansing.
    • Human or animal bite
    • Decubitus etiology
    • Evidence of active infection or gangrene
    • On mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips)
    • On an area which may be regularly exposed to body fluids or with dense natural hair, (e.g., scalp)
    • Under tension or over a joint

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01716013

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United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
DC Cosmetics
Chevy Chase, Maryland, United States, 20815
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sadick Research Group
New York, New York, United States, 10075
United States, North Carolina
Wake Forest Baptist Health
Wake Forest, North Carolina, United States, 27157
Sponsors and Collaborators
OptMed, Inc.
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Responsible Party: OptMed, Inc. Identifier: NCT01716013    
Other Study ID Numbers: PD-100-002
First Posted: October 29, 2012    Key Record Dates
Results First Posted: November 18, 2016
Last Update Posted: January 9, 2017
Last Verified: November 2016
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries