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

NCT05710705 | Unknown

• 1 other identifier: PI2022_843_0040
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction; Thrombosis, Venous; Bioimpedance Measurement Capacity

Keywords

breast reconstruction; Thrombosis, Venous; bioimpedance measurement capacity

Outcome Measures

Primary Outcomes (1)

• Measurement of impedence

  Impedence measurement during episode of ischemia.

  one day

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman undergoing microsurgical breast reconstruction using a free abdominal flap
• Age greater than or equal to 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Raphael SINNA, Pr

CONTACT

03 22 08 90 04; sinna.raphael@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: February 2, 2023
• Study Start: December 8, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 2, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)