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
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|
- • 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 ]
- • 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 ]
- • 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 ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
topical skin adhesive
|Active Comparator: CWCD||
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.
|United States, Florida|
|Orlando Regional Medical Center||Recruiting|
|Orlando, Florida, United States, 32806|
|Contact: Paula Willett 321-841-1204 firstname.lastname@example.org|
|Principal Investigator: Philip Giordano, MD|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Rose Hughart 312-695-1982 email@example.com|
|Principal Investigator: Murad Alam, MD|