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

Not Applicable
Recruiting
Conditions
Breast Reconstruction
Thrombosis, Venous
Bioimpedance Measurement Capacity
Registration Number
NCT05710705
Lead Sponsor
Centre Hospitalier Universitaire, Amiens
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
10
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Measurement of impedenceone day

Impedence measurement during episode of ischemia.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

CHU Amiens

🇫🇷

Amiens, France

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