Bioimpedance Variation of Free Flap for After Clamping

Study Overview
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Brief Summary
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MONITRANS project consist of developing a monitoring technology of post-operative breast reconstruction by detecting thrombosis. Its aim is to reducing time spent in hospital by monitoring patients at home. Thrombosis following to abdominal free flap harvesting for breast reconstruction is a rare phenomenon (with a 2 until 15 % frequency). Moreover, it leads to ischemia by limiting water intake in the plasma compartments. The investigator would like to prove, by this research project, that they are able to detect ischemia via bioimpedance technology. During abdominal free flap harvesting for breast reconstruction, there are few minutes where the flap is clamped because of anastomosis on the recipient vessels. The investigators would seize the opportunity of this step, which is similar to vascular thrombosis, to measure bioimpedance variations. Therefore they would like to measure variations of the flap bioimpedance before and after vascular section. Another purpose consists of developing an algorithm which will detect postoperative thrombosis.

Official Title
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Bioimpedance Variation of Free Flap for After Clamping - MONITRANS

Conditions
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Thrombosis

Intervention / Treatment
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* Device: Measurement of the flap bioimpedance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient suitable for a abdominal perforator based flap breast reconstruction age over 18 years old Exclusion Criteria: pregnancy women with active pacemaker implant or artificial heart

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Measurement of the flap bioimpedance before and after clamping of the artery or the vein. For information: All patients will have the vein and the arterial section simulating venous or arterial thrombosis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impedance<br>Measurement of the flap bioimpedance before and after clamping of the artery or the vein. For information: All patients will have the vein and the arterial section simulating venous or arterial thrombosis. | Device: Measurement of the flap bioimpedance<br>* Measurement of the flap bioimpedance before and after clamping of the artery or the vein. For information: All patients will have the vein and the arterial section simulating venous or arterial thrombosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of impedence | Measurement of the flap bioimpedance before and after clamping of the artery or the vein. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioimpedance, thrombosis, free flap, microsurgerie, breast reconstruction