跳至主要内容
临床试验/NCT03351387
NCT03351387已完成不适用

Assessment of Wound Necrosis in Lower Extremity Surgery Using SPY Intra-operative Angiography

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年10月20日最近更新:
适应症

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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brandon James Yuan

Principal Investigator

Mayo Clinic

研究点 (1)

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