Breast Cancer, Fat Necrosis, Vascularization
Conditions
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.
Interventions
PROCEDURETailoring 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.
PROCEDURETailoring 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.
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Number of participants with flap failure as assessed by physical examination | From intraoperative moment to one week postoperatively |
| 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 |
| Flap length (centimeters) | Intraoperatively |
| Number of participants with wound infection as assessed by physical examination | From one day postoperatively to two weeks postoperatively |
Countries
Spain
Outcome results
None listed