Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

I

Instituto de Investigación Hospital Universitario La Paz

Status

Completed

Conditions

Breast Cancer
Vascularization
Fat Necrosis

Treatments

Procedure: Tailoring the flap according to clinical assessment
Procedure: Tailoring the flap according to ICG Angiography assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT02759796
idipaz

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups, including a placebo group

Clinical assessment of flap perfusion
Placebo Comparator group
Description:
Tailoring the flap according to clinical assessment of flap perfusion
Treatment:
Procedure: Tailoring the flap according to clinical assessment
Angiography assessment of flap perfusion
Experimental group
Description:
Tailoring the flap according to ICG Angiography assessment of flap perfusion
Treatment:
Procedure: Tailoring the flap according to ICG Angiography assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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