Use of 2-octylcyanoacrylate (Dermabond) During Cutaneous Wound Closure With Full-thickness Skin Grafts: a Randomized Split Wound Comparative Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Appearance of Scar on the Patient and Observer Scar Assessment Scale
研究概览
简要总结
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures.
详细描述
The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures. Our aims are to compare outcomes using a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with sutures, per the standard of care. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. Our hypothesis is that 2-octylcyanoacrylate will result in cosmetically superior wound outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Over 18 years of age
- •Able to give informed consent themselves
- •Patient scheduled for cutaneous surgical procedure with predicted closure with full-thickness skin graft
- •Willing to return for follow-up visits
排除标准
- •Mentally handicapped
- •Unable to understand written and oral English
- •Incarceration
- •Under 18 years of age
- •Pregnant Women
- •Patients on systemic steroid therapies
- •Patients with Marfans
- •Patients with allergies to 2-octylcyanoacrylate
结局指标
主要结局
Appearance of Scar on the Patient and Observer Scar Assessment Scale
时间窗: 3 months
After surgical procedure, half of the subject's wound will be with 2-octylcyanoacrylate, while the other half is closed 5-0 vicryl sutures. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
次要结局
- Incidence of Graft Failure on Case Report(3 months)
- Incidence of Complications on Case Report(3 months)