Breast Cancer Clinical Trial
Official title:
Indocyanine Green Fluorescence Angiography in the Assessment of Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
Verified date | April 2017 |
Source | Instituto de Investigación Hospital Universitario La Paz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | La Paz University Hospital | Madrid |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Hospital Universitario La Paz |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with fat necrosis as assessed by physical examination | Six months postoperatively | ||
Primary | Number of participants with fat necrosis as assessed by ultrasonography | Six months postoperatively | ||
Secondary | Number of participants with flap failure as assessed by physical examination | From intraoperative moment to one week postoperatively | ||
Secondary | Number of participants with wound infection as assessed by physical examination | From one day postoperatively to two weeks postoperatively | ||
Secondary | Number of participants with wound healing delay as assessed by physical examination | From two weeks postoperatively to two months postoperatively | ||
Secondary | Number of participants with reoperation | From immediate postoperative moment to one year postoperatively | ||
Secondary | Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System) | Intraoperatively | ||
Secondary | Flap weight (grams) | Intraoperatively | ||
Secondary | Flap length (centimeters) | Intraoperatively | ||
Secondary | Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status | A preoperative test in the last week before surgery | ||
Secondary | Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status | A postoperative test one year after surgery | ||
Secondary | ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring) | Intraoperatively |
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