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Bioimpedance Variation of Free Flap for After Clamping

NCT03118115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-08-10

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Measurement of the flap bioimpedance

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • Raphaël SINNA, MD, PhD · CHU Amiens

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2017-05-19
Completion
2017-05-19

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03118115 on ClinicalTrials.gov