Fluorescence Angiography in the Assessment of DIEP Flap Perfusion (NCT02759796) | Clinical Trial Compass
CompletedNot Applicable
Fluorescence Angiography in the Assessment of DIEP Flap Perfusion
Spain60 participantsStarted 2015-11
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with fat necrosis as assessed by physical examination
Timeframe: Six months postoperatively
2
Number of participants with fat necrosis as assessed by ultrasonography
Timeframe: Six months postoperatively
Trial details
NCT IDNCT02759796
SponsorInstituto de Investigación Hospital Universitario La Paz