The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Rate of Wound Closure
研究概览
简要总结
A case series involving the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing.
详细描述
This is a prospective case series examining the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing. Wound healing will be evaluated at 2 weeks, 6 weeks, and 3 months. If subjects heal prior to the 3 month visit, wound healing will be documented at that visit. A maximum of ten subjects will be included in this series.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a clinical diagnosis of pilonidal disease.
- •Subject is being scheduled for surgical excision of pilonidal disease.
- •Subject is at least 18 years of age.
- •Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
- •Subject is willing to provide written informed consent.
排除标准
- •Subject has a known allergy to porcine-based materials.
- •Subject is pregnant
结局指标
主要结局
Rate of Wound Closure
时间窗: Up to 3 month visit
The study was terminated by Sponsor; no outcome measure data analyses were conducted.
次要结局
未报告次要终点