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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OptMed, Inc.
- 入组人数
- 162
- 试验地点
- 11
- 主要终点
- 100% Wound Apposition at 10 Days
研究概览
简要总结
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™.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
100% Wound Apposition at 10 Days
时间窗: 10 days
Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.
次要结局
- Optimal Cosmetic Outcome at 28 Days (Score of 6)(28 days)
- ≥ 50% Wound Apposition at 10 Days(10 days)