Clinical Trial: Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Indocyanine Green Fluorescence Angiography in the Assessment of Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion

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.

Detailed Summary:
Sponsor: Instituto de Investigación Hospital Universitario La Paz

Current Primary Outcome:

  • Number of participants with fat necrosis as assessed by physical examination [ Time Frame: Six months postoperatively ]
  • Number of participants with fat necrosis as assessed by ultrasonography [ Time Frame: Six months postoperatively ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with flap failure as assessed by physical examination [ Time Frame: From intraoperative moment to one week postoperatively ]
  • Number of participants with wound infection as assessed by physical examination [ Time Frame: From one day postoperatively to two weeks postoperatively ]
  • Number of participants with wound healing delay as assessed by physical examination [ Time Frame: From two weeks postoperatively to two months postoperatively ]
  • Number of participants with reoperation [ Time Frame: From immediate postoperative moment to one year postoperatively ]
  • Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System) [ Time Frame: Intraoperatively ]
  • Flap weight (grams) [ Time Frame: Intraoperatively ]
  • Flap length (centimeters) [ Time Frame: Intraoperatively ]
  • Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status [ Time Frame: A preoperative test in the last week before surgery ]
  • Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status [ Time Frame: 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) [ Time Frame: Intraoperatively ]


Original Secondary Outcome: Same as current

Information By: Instituto de Investigación Hospital Universitario La Paz

Dates:
Date Received: April 5, 2016
Date Started: November 2015
Date Completion:
Last Updated: April 21, 2017
Last Verified: April 2017