Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures
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
- 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 the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •The scar to be revised is:
- •at least 12 months old
- •linear and suitable for revision by excision and direct closure
- •appropriate size and location for Neodyne Dressing
- •The subject:
- •age > 18 and < 65 years old
排除标准
- •Subjects with a skin disorder that is chronic or currently active.
- •Subjects who are involved in ongoing litigation in connection with the scar to be revised.
- •Subjects with a history of collagen vascular disease
- •Subjects diagnosed with scleroderma
- •Subject who currently smokes
- •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.
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
- Comparison of Scar Smoothness of Treated Side as Compared to the Control Side(Up to 12 months)
- Subject and Investigator Satisfaction With the Aesthetic Results(Up to 12 months)
- Ease of Use(Up to 12 months)
- Comfort Level Related to Study Device Application, Wear and Removal(Up to 12 weeks)