Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- wound failure, time lost from work or school, analgesic requirements, recurrence rates
研究概览
简要总结
Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective study that will evaluate the results of surgical pore excision, curettage, and injection of a regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease.
详细描述
In addition, the study will evaluate the credibility and reproducibility of results within other surgeons trained to perform the procedure. Data collection will focus on post-operative wound failure, infection ratwes, analgesic requirements, time lost from work or school, wound care requirements, and 6 month recurrence rates. These outcomes will be compared to outcomes using conventional pilonidal surgical intervention using published data.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with pilonidal diseas
排除标准
- 未提供
结局指标
主要结局
wound failure, time lost from work or school, analgesic requirements, recurrence rates
时间窗: 6 months
次要结局
- infection rates, wound care requirements(6 months)