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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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™.


Detailed Summary:

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.


Sponsor: OptMed, Inc.

Current Primary Outcome: 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.


Original Primary Outcome: • Proportion of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure. [ Time Frame: 10 days ]

Current Secondary Outcome:

  • 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.

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


Original Secondary Outcome:

  • • 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 ]
  • Incidence of wounds ≥50% apposed (10±3 days) [ Time Frame: 10 days ]


Information By: OptMed, Inc.

Dates:
Date Received: October 21, 2012
Date Started: September 2012
Date Completion:
Last Updated: November 17, 2016
Last Verified: November 2016