Assessment of Wound Necrosis in Lower Extremity Surgery Using SPY Intra-operative Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Wound necrosis
研究概览
简要总结
Researchers are performing this study to evaluate if intraoperative angiography can be shown numerically to determine which wounds are at high risk of wound necrosis/breakdown.
详细描述
At the beginning of the Participants surgical procedure, a picture will be obtained using intraoperative angiography using ICG dye which the camera can detect. This dye will be provided through intravenous access. The picture will be taken of the wound to determine preoperative blood flow to the area where the incision is planned. After the wound has been closed postoperatively, a final picture, using the procedure described above, will be taken to determine blood flow after closure of the wound. These images will be obtained using intraoperative angiography. The Participant will be followed after the surgical procedure at standard intervals as determined by the surgeon until the wound heals or requires further intervention.
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
- •Surgical indication for high risk lower extremity surgery
排除标准
- •Previous high risk lower extremity surgery
- •Revision high risk lower extremity surgery
- •Traumatic amputation
- •Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
结局指标
主要结局
Wound necrosis
时间窗: 4 weeks after surgical intervention
Superficial wound necrosis, as evidenced by photography
次要结局
未报告次要终点
研究者
Brandon James Yuan
Principal Investigator
Mayo Clinic
