Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: portable prototype of bioimpedance measurement.
- Who it may be relevant to
- Registry conditions: Breast Reconstruction, Thrombosis, Venous, Bioimpedance Measurement Capacity. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device portable 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.
Primary outcome measures
- Measurement of impedence [Time frame: one day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT05710705 · PI2022_843_0040