Suspended

AFLUFluorescence Angiography With Fluobeam™ Camera (Fluoptics Company): Planning and Monitoring of Perforator Flaps

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What is being tested

Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)

Device
Who is being recruted

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorUniversity Hospital, Grenoble
Last updated: April 18, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

Reconstructive surgery is intended to replace amputated anatomical regions by autologous tissue taken from distant locations: flaps. The goal is to restitute ad integrum with minimal sequelae. Among the flaps available, perforator flaps have the advantage of being highly plastic, large and can be taken from accessory vessels the loss of wich does not compromise the vitality of the sampling site. However their more variable anatomy requires irradiating preoperative morphological assessment (CT angiography) or a doppler ultrasonography that is not always performed by the surgeon himself and does not distinguish between muscle perforator and skin perforator. Fluorescence angiography is a superficial exploration technique of vascularization. After intravenous injection of a tracer (indocyanine green ICG), fluorescence angiography provides useful surface angiographic imaging in real-time. It can also help in monitoring intraoperative and postoperative quality of vascular anastomoses. Although fluorescence angiography has numerous applications (ophthalmology, neurosurgery, liver transplantation...), its usefulness in surgical flaps is only supported by a few publications. None really validate its clinical value by comparing it to reference investigations (CT angiography or doppler ultrasonography). 40 candidate for reconstructive surgery will be included in this study. The day before surgery, in addition to the usual technique used to locate perforator flaps, the patient will receive an injection of 0.025 mg / kg Infracyanine® (indocyanine green) and the area of interest of the flap will be explored with the Fluobeam™ camera. Two hours after the surgery, during the usual clinical monitoring of the vitality of the flap, a new injection of Infracyanine® will test perfusion of the flap by measuring fluorescence intensity of the target area. These measurement will then be repeated every 6 hours for 4 days.

Principal SponsorUniversity Hospital, Grenoble
Last updated: April 18, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
consenting patient

perforator flap reconstruction whatever the indication (cancer, trauma, malformations). The main targets are the fibula flaps, anterolateral thigh flaps and inferior epigastric flaps

2 exclusion criteria prevent from participating
known indocyanine green allergy

pregnant woman, parturient woman or nursing woman

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The surgeon will prescribe the usual morphological assessment of the proposed flap: CT angiography for an anterolateral thigh flap or an epigastric inferior flap A Doppler ultrasonography for a fibula flap. In addition to the usual radiological technique used to locate the perforating arteries, the patient will have a fluorescence angiography prior to surgery, another just after the end of surgery and then one every six hours during the next 4 days.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospital of Grenoble

Grenoble, FranceOpen University Hospital of Grenoble in Google Maps
SuspendedOne Study Center