Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

Indocyanine Green Fluorescence Angiography in the Assessment of Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Vascularization; Fat Necrosis
• Intervention / Treatment: Procedure: Tailoring the flap according to clinical assessment; Procedure: Tailoring the flap according to ICG Angiography assessment

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • La Paz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Clinical assessment of flap perfusion; Tailoring the flap according to clinical assessment of flap perfusion	Procedure: 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.
EXPERIMENTAL: Angiography assessment of flap perfusion; Tailoring the flap according to ICG Angiography assessment of flap perfusion	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with fat necrosis as assessed by physical examination	Six months postoperatively
Number of participants with fat necrosis as assessed by ultrasonography	Six months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with flap failure as assessed by physical examination	From intraoperative moment to one week postoperatively
Number of participants with wound infection as assessed by physical examination	From one day postoperatively to two weeks postoperatively
Number of participants with wound healing delay as assessed by physical examination	From two weeks postoperatively to two months postoperatively
Number of participants with reoperation	From immediate postoperative moment to one year postoperatively
Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)	Intraoperatively
Flap weight (grams)	Intraoperatively
Flap length (centimeters)	Intraoperatively
Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status	A preoperative test in the last week before surgery
Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status	A postoperative test one year after surgery
ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring)	Intraoperatively

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Investigators: Principal Investigator: Luis Landín Jarillo, MD, PhD, La Paz University Hospital

Publications and helpful links

General Publications

• Varela R, Casado-Sanchez C, Zarbakhsh S, Diez J, Hernandez-Godoy J, Landin L. Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial. Plast Reconstr Surg. 2020 Jan;145(1):1-10. doi: 10.1097/PRS.0000000000006393.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): April 1, 2017

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (ESTIMATE): May 3, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Necrosis; Neovascularization, Pathologic; Fat Necrosis
• Other Study ID Numbers: idipaz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO