Bioimpedance Variation of Free Flap for After Clamping

NCT03118115 | Completed

• 1 other identifier: PI2016_843_0028
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Thrombosis

Keywords

bioimpedance; thrombosis; free flap; microsurgerie; breast reconstruction

Outcome Measures

Primary Outcomes (1)

• Measurement of impedence

  Measurement of the flap bioimpedance before and after clamping of the artery or the vein.

  1 day

Study Arms (1)

Impedance

EXPERIMENTAL

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.

Device: Measurement of the flap bioimpedance

Interventions

Measurement of the flap bioimpedance DEVICE

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.

Impedance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient suitable for a abdominal perforator based flap breast reconstruction
• age over 18 years old

You may not qualify if:

• pregnancy
• women with active pacemaker implant or artificial heart

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raphaël SINNA, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 18, 2017
• Study Start: May 10, 2017
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)