Bioimpedance Variation of Free Flap for After Clamping

Not Applicable

Completed

• Conditions: Thrombosis
• Interventions: Device: Measurement of the flap bioimpedance

• Registration Number: NCT03118115
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

MONITRANS project consist of developing a monitoring technology of post-operative breast reconstruction by detecting thrombosis. Its aim is to reducing time spent in hospital by monitoring patients at home.

Thrombosis following to abdominal free flap harvesting for breast reconstruction is a rare phenomenon (with a 2 until 15 % frequency). Moreover, it leads to ischemia by limiting water intake in the plasma compartments. The investigator would like to prove, by this research project, that they are able to detect ischemia via bioimpedance technology.

During abdominal free flap harvesting for breast reconstruction, there are few minutes where the flap is clamped because of anastomosis on the recipient vessels. The investigators would seize the opportunity of this step, which is similar to vascular thrombosis, to measure bioimpedance variations.

Therefore they would like to measure variations of the flap bioimpedance before and after vascular section. Another purpose consists of developing an algorithm which will detect postoperative thrombosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-18
• Study Start: 2017-05-10
• Primary Completion: 2017-05-19
• Study Completion: 2017-05-19
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• patient suitable for a abdominal perforator based flap breast reconstruction
• age over 18 years old

Exclusion Criteria

• pregnancy
• women with active pacemaker implant or artificial heart

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Impedance	Measurement of the flap bioimpedance	Measurement of the flap bioimpedance before and after clamping of the artery or the vein. For information: All patients will have the vein and the arterial section simulating venous or arterial thrombosis.

Primary Outcome Measures

Name	Time	Method
Measurement of impedence	1 day	Measurement of the flap bioimpedance before and after clamping of the artery or the vein.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France