MONITRANS2: Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05710705
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 11.8
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Reconstruction; Thrombosis, Venous; Bioimpedance Measurement Capacity	Device: portable prototype of bioimpedance measurement	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
• Actual Study Start Date: Dec 8, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. Measurement of impedence [one day]

   Impedence measurement during episode of ischemia.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80054

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT05710705
• Other Study ID Numbers: PI2022_843_0040
• First Posted: Feb 2, 2023
• Last Update Posted: Feb 2, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire, Amiens: breast reconstruction; Thrombosis, Venous; bioimpedance measurement capacity
• Additional relevant MeSH terms: Thrombosis; Venous Thrombosis

Study Results

No Results Posted as of Feb 2, 2023