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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
OptMed, Inc.
ClinicalTrials.gov Identifier:
NCT01716013
First received: October 21, 2012
Last updated: January 4, 2014
Last verified: January 2014
  Purpose

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 Intervention
Traumatic Lacerations or Surgical Incisions
Device: BondEase
Procedure: CWCD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by OptMed, Inc.:

Primary Outcome Measures:
  • • Proportion of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days (and 90 days Part 1 only) [ Time Frame: 28 Days and 90 days ] [ Designated as safety issue: No ]
  • Incidence of wounds ≥50% apposed (10±3 days) [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • • Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up [ Time Frame: 28 Days and 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 153
Study Start Date: September 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BondEase Device: BondEase
topical skin adhesive
Active Comparator: CWCD Procedure: CWCD
traditional closure methods of sutures, staples or adhesive strips

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716013

Locations
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.
  More Information

No publications provided

Responsible Party: OptMed, Inc.
ClinicalTrials.gov Identifier: NCT01716013     History of Changes
Other Study ID Numbers: PD-100-002
Study First Received: October 21, 2012
Last Updated: January 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on October 02, 2014