Traumatic Lacerations or Surgical Incisions Clinical Trial
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
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™.
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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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment