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

Breast Reconstruction Clinical Trial

— MONITRANS2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710705
• Other study ID #: PI2022_843_0040
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Reconstruction
• Thrombosis
• Thrombosis, Venous
• Venous Thrombosis

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