Bioimpedance Variation of Free Flap for After Clamping (MONITRANS)
Primary Purpose
Thrombosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measurement of the flap bioimpedance
Sponsored by
About this trial
This is an interventional basic science trial for Thrombosis focused on measuring bioimpedance, thrombosis, free flap, microsurgerie, breast reconstruction
Eligibility Criteria
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
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Impedance
Arm Description
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.
Outcomes
Primary Outcome Measures
Measurement of impedence
Measurement of the flap bioimpedance before and after clamping of the artery or the vein.
Secondary Outcome Measures
Full Information
NCT ID
NCT03118115
First Posted
March 22, 2017
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03118115
Brief Title
Bioimpedance Variation of Free Flap for After Clamping
Acronym
MONITRANS
Official Title
Bioimpedance Variation of Free Flap for After Clamping - MONITRANS
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
May 19, 2017 (Actual)
Study Completion Date
May 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
bioimpedance, thrombosis, free flap, microsurgerie, breast reconstruction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Impedance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Measurement of the flap bioimpedance
Intervention Description
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 Measure Information:
Title
Measurement of impedence
Description
Measurement of the flap bioimpedance before and after clamping of the artery or the vein.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphaël SINNA, MD, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bioimpedance Variation of Free Flap for After Clamping
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