Objective Flap Assessment During Reconstructive Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-02-29

Brief Summary

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The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.

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Detailed Description

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To perform a pilot study of the FLARE™ NIR fluorescence imaging system in conjunction with indocyanine green (ICG) during breast reconstructive surgery utilizing deep inferior epigastric perforator (DIEP) flaps.

Due to patient-to-patient anatomic variation, the vascular perfusion to the cutaneous elements in flaps is unpredictable and of great concern to the surgeon planning the design of the flap. We propose a method of imaging the flap based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon.

Specific Aims:

A pilot optimization study of the imaging system in combination with ICG to determine optimal dose, light excitation fluence rate, and camera exposure time.

Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Imaging system operation

Group Type EXPERIMENTAL

FLARE imaging system

Intervention Type DEVICE

Testing of operation of imaging system

Interventions

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FLARE imaging system

Testing of operation of imaging system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy.
* Women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist.