Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)
研究概览
简要总结
This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.
详细描述
This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects who have undergone an abdominoplasty 1 week prior to study participation
排除标准
- •subjects with a history of collagen vascular disease or scleroderma
- •subjects with known adverse reactions to steri-strips, medical tapes or adhesives
结局指标
主要结局
Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)
时间窗: through 12 months
Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint.
次要结局
未报告次要终点