NCT00798798撤回不适用
Effect of Externally Implantable Tissue Expansion Device on Scar Length
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Surface area (in cm2) of subject's scar
研究概览
简要总结
The purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. The secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ages 18-80 years old
- •Subjects who are undergoing an excision of a large cutaneous lesion
- •Subjects with an immediate post-excision wound defect at least 2.5 cm in diameter
- •Subjects undergoing surgery on the trunk or extremities
- •The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
- •Subjects who are willing to undergo no other treatments for the scars for the duration of the study.
排除标准
- •Subjects with scalp wounds
- •Subjects who are unable to understand the protocol or give informed consent
研究组 & 干预措施
Implantable Tissue Expansion Device
Experimental
Will apply externally implantable tissue expansion device for 2 days
干预措施: Externally Implantable Tissue Expansion Device (Device)
结局指标
主要结局
Surface area (in cm2) of subject's scar
时间窗: 3 months
次要结局
- Treating physicians will note any adverse effects(3 months)
研究者
Murad Alam
MD
Northwestern University
研究点 (1)
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