Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction (MONITRANS2)
Primary Purpose
Breast Reconstruction, Thrombosis, Venous, Bioimpedance Measurement Capacity
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
portable prototype of bioimpedance measurement
Sponsored by
About this trial
This is an interventional other trial for Breast Reconstruction focused on measuring breast reconstruction, Thrombosis, Venous, bioimpedance measurement capacity
Eligibility Criteria
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
Sites / Locations
- CHU AmiensRecruiting
Outcomes
Primary Outcome Measures
Measurement of impedence
Impedence measurement during episode of ischemia.
Secondary Outcome Measures
Full Information
NCT ID
NCT05710705
First Posted
December 8, 2022
Last Updated
January 24, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05710705
Brief Title
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
Acronym
MONITRANS2
Official Title
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Reconstruction, Thrombosis, Venous, Bioimpedance Measurement Capacity
Keywords
breast reconstruction, Thrombosis, Venous, bioimpedance measurement capacity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
portable prototype of bioimpedance measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of impedence
Description
Impedence measurement during episode of ischemia.
Time Frame
one day
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
breast reconstruction
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raphael SINNA, Pr
Phone
03 22 08 90 04
Email
sinna.raphael@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphaël SINNA, MD, PhD
Phone
+33 3 22 08 90 04
Email
sinna.raphael@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
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