Safety and Efficacy Study of BondEase to Treat 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™.
|Study Design:||Allocation: Randomized
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|
- 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.
- 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)
- 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
|Study Start Date:||September 2012|
|Study Completion Date:||February 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Topical Skin Adhesive
topical skin adhesive
Active Comparator: CWCD
Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
traditional closure methods of sutures, staples or adhesive strips
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716013
|United States, Florida|
|Orlando Regional Medical Center|
|Orlando, Florida, United States, 32806|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|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|