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NCT Number: NCT05710705

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

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.

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Key information

Conditions

Breast Reconstruction Bioimpedance Measurement Capacity Cardiovascular Diseases Embolism and Thrombosis Thrombosis Thrombosis, Venous Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

portable prototype of bioimpedance measurement

Device

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 outcomes

  1. Measurement of impedence

    Time frame: one day

    Impedence measurement during episode of ischemia.

Study contacts

Contact information is provided by the study sponsor or research team.

Raphael SINNA, Pr

CONTACT

[email protected]

03 22 08 90 04

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: MONITRANS2

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Feb 2, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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