Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 26
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.
详细描述
It is proposed to study a dressing designed to reduce scarring in post-incision skin tissue. It is expected that by managing the incision site during the healing phase, scar formation may be minimized.
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 a de novo abdominoplasty.
- •Appearance of subject's incision is aesthetically similar across length of incision.
排除标准
- •Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
- •Subjects diagnosed with scleroderma.
- •Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
- •Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
- •Subjects with inability to maintain adequate care of incision.
- •Subjects with a body mass index (BMI) >
- •Subjects with a weight loss of greater than or equal to 100 lbs within 6 months from date of abdominoplasty.
- •Subjects who currently smoke.
- •Subjects taking steroid therapy.
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 6 months
Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006\[1\]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome. \[1\] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006.
次要结局
- Patient and Observer Scar Assessment Scale (POSAS) - Patient Results(12 Months)
- Patient and Observer Scar Assessment Scale (POSAS) - Observer Results(12 Months)
- Patient Satisfaction - Scar Minimization(12 Months)
- Patient Satisfaction - Recommend(12 Months)
- Patient Satisfaction - Use Again(12 Months)