Clinical trial NCT01681797: Fluorescence Angiography: Planning and Monitoring of Perforator Flaps
Official title: Fluorescence Angiography With Fluobeam™ Camera (Fluoptics Company): Planning and Monitoring of Perforator Flaps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Reconstructive Surgery
Keywords: fluorescent angiography
reconstructive surgery
perforator flap
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether fluorescence angiography is an effectiveness technique for the localization of vascular perforators and their area of perfusion and for the postoperative monitoring of flap perfusion.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* known indocyanine green allergy
* pregnant woman, parturient woman or nursing woman

Primary outcomes:
measure: Comparison between the position of perforator flap determined by fluorescence angiography and the real anatomic position of the flap determined after dissection
timeFrame: During the first fluorescent angiography
Secondary outcomes:
measure: Comparison between the position of the perforator flap determined by fluorescence angiography and the position of the flap determined by reference imaging techniques relevant to the flap (CT angiography or doppler ultrasonography)
timeFrame: During the first fluorescent angiography
measure: Intraoperative monitoring of the quality of micro-vascular anastomoses using fluorescent angiography
timeFrame: Just after micro-vascular anastomoses
measure: Postoperative monitoring of flap perfusion using fluorescence angiography
timeFrame: Every six hours for four days after surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
state: Isere
Study officials:
affiliation: University Hospital, Grenoble
name: Georges BETTEGA, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koenig A, Herve L, Gonon G, Josserand V, Berger M, Dinten JM, Boutet J, Peltie P, Coll JL, Rizo P. Fluorescence diffuse optical tomography for free-space and multifluorophore studies. J Biomed Opt. 2010 Jan-Feb;15(1):016016. doi: 10.1117/1.3309738.