Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction (MONITRANS2)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

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

Treatments: Device: portable prototype of bioimpedance measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT05710705

PI2022_843_0040

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind