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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05710705
Other study ID # PI2022_843_0040
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 8, 2022
Est. completion date December 2023

Study information

Verified date December 2022
Source Centre Hospitalier Universitaire, Amiens
Contact Raphael SINNA, Pr
Phone 03 22 08 90 04
Email sinna.raphael@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Device:
portable prototype of bioimpedance measurement
The device will be installed during the patient's operation. It will be attached to the healthy skin of the flap (without wound or scar) by sterile glue. It will then be covered with a self-adhesive "tegaderm" type dressing. The wound will be isolated from the device with a hermetic silicone dressing of the "Mepilex" type, for example. There will therefore be no communication between the measuring device and the surgical wound.

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of impedence Impedence measurement during episode of ischemia. one day
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