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Completed

NCT Number: NCT02759796

Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Fat Necrosis Metaplasia Necrosis Neoplasms Neoplasms by Site Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Vascularization

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

La Paz University Hospital

Madrid, 28046, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tailoring the flap according to clinical assessment

Procedure

After microvascular anastomosis is performed, the investigators clinically assess flap vascularization and the well vascularized tissue is marked by means of a dermographic pencil. Then the investigators administer 0,2mg/kg of ICG intravenously. The vascularization of the flap is also checked by means of the Photo Dynamic Eye (Pulsion Medical System) but finally the decision of discarding the poorly vascularized areas of the flap is made by clinical assessment.

Tailoring the flap according to ICG Angiography assessment

Procedure

After microvascular anastomosis is performed, the investigators administer 0,2mg/kg of ICG intravenously. Then the investigators check the vascularization of the flap by means of the Photo Dynamic Eye (Pulsion Medical System) and the poorly vascularized areas of the flap are discarded guided by ICG perfusion test.

Primary outcomes

  1. Number of participants with fat necrosis as assessed by physical examination

    Time frame: Six months postoperatively

  2. Number of participants with fat necrosis as assessed by ultrasonography

    Time frame: Six months postoperatively

Secondary outcomes

  1. Number of participants with flap failure as assessed by physical examination

    Time frame: From intraoperative moment to one week postoperatively

  2. Number of participants with wound infection as assessed by physical examination

    Time frame: From one day postoperatively to two weeks postoperatively

  3. Number of participants with wound healing delay as assessed by physical examination

    Time frame: From two weeks postoperatively to two months postoperatively

  4. Number of participants with reoperation

    Time frame: From immediate postoperative moment to one year postoperatively

  5. Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)

    Time frame: Intraoperatively

  6. Flap weight (grams)

    Time frame: Intraoperatively

  7. Flap length (centimeters)

    Time frame: Intraoperatively

  8. Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status

    Time frame: A preoperative test in the last week before surgery

  9. Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status

    Time frame: A postoperative test one year after surgery

  10. ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring)

    Time frame: Intraoperatively

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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