跳至主要内容
临床试验/NCT05710705
NCT05710705招募中不适用

Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年12月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Measurement of impedence

研究概览

简要总结

As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model.

The patients will benefit from an "improved" postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours.

This protocol is therefore a feasibility study for the collection of data of interest.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Woman undergoing microsurgical breast reconstruction using a free abdominal flap
  • •Age greater than or equal to 18 years

排除标准

  • •Pregnant patient
  • •Patient with an active implantable device such as a pacemaker or an artificial heart
  • •Patient refusing to participate in the study
  • •Age less than 18 years old

结局指标

主要结局

Measurement of impedence

时间窗: one day

Impedence measurement during episode of ischemia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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