NCT05710705

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Reconstruction
• Thrombosis, Venous
• Bioimpedance Measurement Capacity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-08
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-02-02
• Last updated: 2023-02-02

Locations

1 site across 1 country: France