Clinical trial NCT02759796: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Vascularization
Fat Necrosis
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Number of participants with fat necrosis as assessed by physical examination
timeFrame: Six months postoperatively
measure: Number of participants with fat necrosis as assessed by ultrasonography
timeFrame: Six months postoperatively
Secondary outcomes:
measure: Number of participants with flap failure as assessed by physical examination
timeFrame: From intraoperative moment to one week postoperatively
measure: Number of participants with wound infection as assessed by physical examination
timeFrame: From one day postoperatively to two weeks postoperatively
measure: Number of participants with wound healing delay as assessed by physical examination
timeFrame: From two weeks postoperatively to two months postoperatively
measure: Number of participants with reoperation
timeFrame: From immediate postoperative moment to one year postoperatively
measure: Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)
timeFrame: Intraoperatively
measure: Flap weight (grams)
timeFrame: Intraoperatively
measure: Flap length (centimeters)
timeFrame: Intraoperatively
measure: Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status
timeFrame: A preoperative test in the last week before surgery
measure: Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status
timeFrame: A postoperative test one year after surgery
measure: ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring)
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: La Paz University Hospital
name: Luis Landín Jarillo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.