Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

Study Overview
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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.

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

Conditions
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Breast Cancer, Vascularization, Fat Necrosis

Intervention / Treatment
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* Procedure: Tailoring the flap according to clinical assessment
* Procedure: Tailoring the flap according to ICG Angiography assessment


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Clinical assessment of flap perfusion<br>Tailoring the flap according to clinical assessment of flap perfusion | Procedure: Tailoring the flap according to clinical assessment<br>* 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.<br>|
| Experimental: Angiography assessment of flap perfusion<br>Tailoring the flap according to ICG Angiography assessment of flap perfusion | Procedure: Tailoring the flap according to ICG Angiography assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |