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Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

Primary Purpose

Breast Cancer, Vascularization, Fat Necrosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Tailoring the flap according to clinical assessment
Tailoring the flap according to ICG Angiography assessment
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • La Paz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Clinical assessment of flap perfusion

Angiography assessment of flap perfusion

Arm Description

Tailoring the flap according to clinical assessment of flap perfusion

Tailoring the flap according to ICG Angiography assessment of flap perfusion

Outcomes

Primary Outcome Measures

Number of participants with fat necrosis as assessed by physical examination
Number of participants with fat necrosis as assessed by ultrasonography

Secondary Outcome Measures

Number of participants with flap failure as assessed by physical examination
Number of participants with wound infection as assessed by physical examination
Number of participants with wound healing delay as assessed by physical examination
Number of participants with reoperation
Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)
Flap weight (grams)
Flap length (centimeters)
Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status
Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status
ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring)

Full Information

First Posted
April 5, 2016
Last Updated
April 21, 2017
Sponsor
Instituto de Investigación Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT02759796
Brief Title
Fluorescence Angiography in the Assessment of DIEP Flap Perfusion
Official Title
Indocyanine Green Fluorescence Angiography in the Assessment of Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Vascularization, Fat Necrosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical assessment of flap perfusion
Arm Type
Placebo Comparator
Arm Description
Tailoring the flap according to clinical assessment of flap perfusion
Arm Title
Angiography assessment of flap perfusion
Arm Type
Experimental
Arm Description
Tailoring the flap according to ICG Angiography assessment of flap perfusion
Intervention Type
Procedure
Intervention Name(s)
Tailoring the flap according to clinical assessment
Intervention Description
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
Intervention Name(s)
Tailoring the flap according to ICG Angiography assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with fat necrosis as assessed by physical examination
Time Frame
Six months postoperatively
Title
Number of participants with fat necrosis as assessed by ultrasonography
Time Frame
Six months postoperatively
Secondary Outcome Measure Information:
Title
Number of participants with flap failure as assessed by physical examination
Time Frame
From intraoperative moment to one week postoperatively
Title
Number of participants with wound infection as assessed by physical examination
Time Frame
From one day postoperatively to two weeks postoperatively
Title
Number of participants with wound healing delay as assessed by physical examination
Time Frame
From two weeks postoperatively to two months postoperatively
Title
Number of participants with reoperation
Time Frame
From immediate postoperative moment to one year postoperatively
Title
Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)
Time Frame
Intraoperatively
Title
Flap weight (grams)
Time Frame
Intraoperatively
Title
Flap length (centimeters)
Time Frame
Intraoperatively
Title
Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status
Time Frame
A preoperative test in the last week before surgery
Title
Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status
Time Frame
A postoperative test one year after surgery
Title
ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring)
Time Frame
Intraoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Landín Jarillo, MD, PhD
Organizational Affiliation
La Paz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Paz University Hospital
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31577664
Citation
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.
Results Reference
derived

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Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

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