Bioimpedance Measurement Capacity, Breast Reconstruction, Thrombosis, Venous
Conditions
Keywords
breast reconstruction, Thrombosis, Venous, bioimpedance measurement capacity
Brief summary
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.
Interventions
DEVICEportable prototype of bioimpedance measurement
The 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.
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman undergoing microsurgical breast reconstruction using a free abdominal flap * Age greater than or equal to 18 years
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of impedence | one day | Impedence measurement during episode of ischemia. |
Countries
France
Contacts
CONTACTRaphael SINNA, Pr
Outcome results
None listed