Bioimpedance Variation of Free Flap for After Clamping (MONITRANS)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Thrombosis

Treatments: Device: Measurement of the flap bioimpedance

Study type: Interventional

Funder types: Other

Identifiers

NCT03118115

PI2016_843_0028

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Impedance

Experimental group

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.

Treatment:

Device: Measurement of the flap bioimpedance