Indocyanine Green Fluorescence Angiography in the Assessment of Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of participants with fat necrosis as assessed by physical examination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of participants with fat necrosis as assessed by physical examination
时间窗: Six months postoperatively
Number of participants with fat necrosis as assessed by ultrasonography
时间窗: Six months postoperatively
次要结局
- 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)