Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-04-30

Brief Summary

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It is a single-center, prospective, randomized and controlled study focused in microsurgical autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography for the study of the vascularization of DIEP flaps. The aim of the study is to determine whether there are differences in complications and aesthetic results when ICG is used to discard the poorly vascularized areas of the flap. The study includes adult women undergoing unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There are two groups. In group 1, the investigators use the usual clinical criteria to discard the poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape the flap.

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Detailed Description

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Conditions

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Breast Cancer Vascularization Fat Necrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Clinical assessment of flap perfusion

Tailoring the flap according to clinical assessment of flap perfusion

Group Type PLACEBO_COMPARATOR

Tailoring the flap according to clinical assessment

Intervention Type PROCEDURE

After microvascular anastomosis is performed, the investigators clinically assess flap vascularization and the well vascularized tissue is marked by means of a dermographic pencil. Then the investigators administer 0,2mg/kg of ICG intravenously. The vascularization of the flap is also checked by means of the Photo Dynamic Eye (Pulsion Medical System) but finally the decision of discarding the poorly vascularized areas of the flap is made by clinical assessment.

Angiography assessment of flap perfusion

Tailoring the flap according to ICG Angiography assessment of flap perfusion

Group Type EXPERIMENTAL

Tailoring the flap according to ICG Angiography assessment

Intervention Type PROCEDURE

After microvascular anastomosis is performed, the investigators administer 0,2mg/kg of ICG intravenously. Then the investigators check the vascularization of the flap by means of the Photo Dynamic Eye (Pulsion Medical System) and the poorly vascularized areas of the flap are discarded guided by ICG perfusion test.

Interventions

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Tailoring the flap according to clinical assessment

After microvascular anastomosis is performed, the investigators clinically assess flap vascularization and the well vascularized tissue is marked by means of a dermographic pencil. Then the investigators administer 0,2mg/kg of ICG intravenously. The vascularization of the flap is also checked by means of the Photo Dynamic Eye (Pulsion Medical System) but finally the decision of discarding the poorly vascularized areas of the flap is made by clinical assessment.

Intervention Type PROCEDURE

Tailoring the flap according to ICG Angiography assessment

After microvascular anastomosis is performed, the investigators administer 0,2mg/kg of ICG intravenously. Then the investigators check the vascularization of the flap by means of the Photo Dynamic Eye (Pulsion Medical System) and the poorly vascularized areas of the flap are discarded guided by ICG perfusion test.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Mastectomized adult female patient
* Abdominal flap unilateral breast reconstruction indication
* Alloplastic breast reconstruction sequelae
* Enough amount of abdominal dermofat tissue to shape a breast with a primary closure of the donor site

Exclusion Criteria

* DIEP flap bilateral breast reconstruction indication
* Previous abdominoplasty surgery
* Untreated psychiatric disease
* Untreated infection
* Indocyanine green or iodine hypersensitivity
* Hyperthyroidism, thyroid adenoma or thyroid autonomy
* Any concomitant disease or condition that, in the opinion of the investigator, can make the patient unsuitable to receive a microsurgical technique or to join the research.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No