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

Recruiting now · Not applicable

Conditions studied: Breast Reconstruction, Thrombosis, Venous, Bioimpedance Measurement Capacity

In brief

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.

Key facts

Study ID

NCT05710705

Run by

Centre Hospitalier Universitaire, Amiens

People needed

10

Starts

2022-12-08

Expected to finish

2026-12-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• CHU Amiens — Amiens, France (enrolling)

Full record on ClinicalTrials.gov

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