Fluorescence Angiography in the Assessment of DIEP Flap Perfusion
- Conditions
- Breast CancerVascularizationFat Necrosis
- Interventions
- Procedure: Tailoring the flap according to ICG Angiography assessmentProcedure: Tailoring the flap according to clinical assessment
- Registration Number
- NCT02759796
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angiography assessment of flap perfusion Tailoring the flap according to ICG Angiography assessment Tailoring the flap according to ICG Angiography assessment of flap perfusion Clinical assessment of flap perfusion Tailoring the flap according to clinical assessment Tailoring the flap according to clinical assessment of flap perfusion
- Primary Outcome Measures
Name Time Method 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
Name Time Method ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring) Intraoperatively Number of participants with wound infection as assessed by physical examination From one day postoperatively to two weeks postoperatively Number of participants with flap failure as assessed by physical examination From intraoperative moment to one week postoperatively Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System) Intraoperatively Flap length (centimeters) Intraoperatively Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status A postoperative test one year after surgery 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 weight (grams) Intraoperatively Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status A preoperative test in the last week before surgery
Trial Locations
- Locations (1)
La Paz University Hospital
🇪🇸Madrid, Spain