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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
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.
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.
La Paz University Hospital
Madrid, Spain
Number of participants with fat necrosis as assessed by physical examination
Time frame: Six months postoperatively
Number of participants with fat necrosis as assessed by ultrasonography
Time frame: Six months postoperatively
Number of participants with flap failure as assessed by physical examination
Time frame: From intraoperative moment to one week postoperatively
Number of participants with wound infection as assessed by physical examination
Time frame: From one day postoperatively to two weeks postoperatively
Number of participants with wound healing delay as assessed by physical examination
Time frame: From two weeks postoperatively to two months postoperatively
Number of participants with reoperation
Time frame: From immediate postoperative moment to one year postoperatively
Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)
Time frame: Intraoperatively
Flap weight (grams)
Time frame: Intraoperatively
Flap length (centimeters)
Time frame: Intraoperatively
Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status
Time frame: A preoperative test in the last week before surgery
Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status
Time frame: 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)
Time frame: Intraoperatively
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