The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Rate of CSF leak
研究概览
简要总结
This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a commercial collagen matrix called Duragen. In this study, our sterile, cGMP manufactured collagen hydrogel dressing will be seeded with the stromal vascular fraction (SVF) mechanically isolated from lipoaspirate taken intra-operatively. This SVF contains pro-regenerative adipose stem cells (ASCs). The ASC-seeded hydrogel will be used as a supplement to Duragen to reinforce the skull base closure. The goal is to establish safety as well as to secondarily evaluate for effectiveness in reducing CSF leak postoperatively.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >/= 18
- •Planned for skull base surgery
- •Able to understand and willing to sign a written informed consent form
排除标准
- •active skull base infection
- •no plan for DuraGen repair by operating surgeon
结局指标
主要结局
Rate of CSF leak
时间窗: 6 months active participation (date of surgery + 6 months follow up via chart review)
次要结局
- Postoperative infection(6 months active participation (date of surgery + 6 months follow up via chart review))
- Death(6 months active participation (date of surgery + 6 months follow up via chart review))
- Length of hospital stay(6 months active participation (date of surgery + 6 months follow up via chart review))
- Postoperative hematoma(6 months active participation (date of surgery + 6 months follow up via chart review))
- Need for rehospitalization(6 months active participation (date of surgery + 6 months follow up via chart review))
- Need for reoperation(6 months active participation (date of surgery + 6 months follow up via chart review))