Bioimpedance and light-based monitoring during abdominal flap weaning in breast reconstruction
Official title: Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
Run by Centre Hospitalier Universitaire, Amiens · NCT05710705 · Data updated 2026-11-12
This study tests a portable bioimpedance device alongside light and temperature measurements to monitor a breast reconstruction flap during arterial and venous weaning in adult women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | December 8, 2022 |
| Main results expected | December 27, 2023 |
| Study ends | December 2026 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT05710705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women undergoing microsurgical breast reconstruction with a free abdominal flap, 18 years or older, who consent to participate.
✕Probably not a fit
Patients whose flaps do not show detectable changes with the monitoring methods or who choose not to participate may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This feasibility study uses a portable bioimpedance monitor, temperature readings, and optical measurements (green, red, and infrared light) on abdominal free flaps during flap weaning in microsurgical breast reconstruction. Data collection focuses on how these noninvasive sensors reflect flap status as arterial and venous flow are interrupted to transfer the flap. Patients will receive standard clinical monitoring plus ultrasound assessments every 6 hours in the first 24 hours and every 12 hours thereafter for five days. The goal is to determine the practicality and informative value of these sensors for postoperative flap surveillance.
Why it matters
Potential benefit: If successful, the approach could enhance early detection of flap problems and improve postoperative monitoring beyond standard care.
How similar studies have gone: Noninvasive monitoring during flap surgery has shown promise in prior research, but this specific combination of bioimpedance and optical sensing during weaning is novel/limited in evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CHU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Raphael SINNA, Pr
- Email: sinna.raphael@chu-amiens.fr
- Phone: 03 22 08 90 04
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.