Ireland
--:--IST
Recruiting Not applicable

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

NCT05710705 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-12-08
Last updated
2026-06-24

Condition(s) studied

Breast ReconstructionThrombosis, VenousBioimpedance Measurement Capacity

Investigational drug(s) / intervention(s)

portable prototype of bioimpedance measurement

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Measurement of impedence — one day
    Impedence measurement during episode of ischemia.

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05710705 on ClinicalTrials.gov ↗ ← All trials in France