About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Woman undergoing microsurgical breast reconstruction using a free abdominal flap
Age greater than or equal to 18 years
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
portable prototype of bioimpedance measurement
DeviceThe device will be installed during the patient's operation. It will be attached to the healthy skin of the flap (without wound or scar) by sterile glue. It will then be covered with a self-adhesive "tegaderm" type dressing. The wound will be isolated from the device with a hermetic silicone dressing of the "Mepilex" type, for example. There will therefore be no communication between the measuring device and the surgical wound.
Treatment groups
Trial outcomes
Primary outcomes
Measurement of impedence
Impedence measurement during episode of ischemia.
Sponsors and contacts
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