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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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

Conditions
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Traumatic Lacerations or Surgical Incisions

Intervention / Treatment
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* Device: BondEase
* Procedure: CWCD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Has a wound requiring surgical repair, where the use of a tissue adhesive is appropriate Is in good general health 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: Significant or multiple traumas Known peripheral vascular disease Known diabetes mellitus type 1 or type 2 Known blood clotting disorder Patient or family history of keloid formation or hypertrophy Known HIV seropositivity or is immunocompromised Been treated with an investigational drug or medical device in the past 30 days A hypersensitivity or contraindication to any of the components of BondEase™ Known pre-operative systemic or local infection Any other diseases or conditions which might interfere with the wound healing process 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BondEase<br>Topical Skin Adhesive | Device: BondEase<br>* topical skin adhesive<br>|
| Active Comparator: CWCD<br>Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips | Procedure: CWCD<br>* traditional closure methods of sutures, staples or adhesive strips<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100% Wound Apposition at 10 Days | Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Cosmetic Outcome at 28 Days (Score of 6) | 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. | 28 days | 
| ≥ 50% Wound Apposition at 10 Days | Incidence of wounds ≥50% apposed (10 ± 3 days) | 10 days |