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NCT05710705
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
Conditions: Breast Reconstruction, Thrombosis, Venous, Bioimpedance Measurement Capacity
Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 10
Sponsor: Centre Hospitalier Universitaire, Amiens
Location: France
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.
Eligibility Criteria
Inclusion Criteria:Woman undergoing microsurgical breast reconstruction using a free abdominal flapAge greater than or equal to 18 yearsExclusion Criteria:Pregnant patientPatient with an active implantable device such as a pacemaker or an artificial heartPatient refusing to participate in the studyAge less than 18 years old
Source: ClinicalTrials.gov (NCT05710705). StuddyBuddy aggregates publicly available trial information.