Bioimpedance Variation of Free Flap for After Clamping

Thrombosis Clinical Trial

— MONITRANS  

Official title:

Bioimpedance Variation of Free Flap for After Clamping - MONITRANS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118115
• Other study ID #: PI2016_843_0028
• Status: Completed
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: May 19, 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis

Intervention

Device:
• 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.

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	Measurement of the flap bioimpedance before and after clamping of the artery or the vein.	1 day