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NCT05507710: FAFI

Indocyanine Green for Perfusion Assessment of DIEP Flaps

Status unknown Phase 3 Last updated 19 August 2022
What this trial tests

Phase 3 trial testing Near-infrared fluorescence imaging of perfusion in Fat Necrosis in 280 participants. Status unknown.

Timeline
1 May 2019
Primary endpoint
1 September 2025
1 October 2025

Quick facts

Lead sponsorLeiden University Medical Center
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment280
Start date1 May 2019
Primary completion1 September 2025
Estimated completion1 October 2025
Sites2 locations across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Leiden University Medical Center

Who can join

18 and older, female only, with Fat Necrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Currently during DIEP flap reconstruction, the perfusion of the flap is assessed by the clinical view of the surgeon. Identification of demarcated ischemic zones of the DIEP flap could be optimized by using fluorescence imaging with indocyanine green (ICG) in order to lower the rate of fat necrosis. This study evaluates whether intraoperative perfusion assessment with ICG fluorescence imaging causes a lower rate of fat necrosis compared to conventional intraoperative clinical evaluation of DIEP flaps.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Near-infrared fluorescence angiography with indocyanine green for perfusion assessment of DIEP and msTRAM flaps: A Dutch multicenter randomized controlled trial.
    Tange FP, Verduijn PS, Sibinga Mulder BG, van Capelle L, et al · · 2023 · cited 10× · PMID 37091505 · DOI 10.1016/j.conctc.2023.101128
  2. Establishing reference curves for vital tissue perfusion using quantitative near-infrared fluorescence imaging with indocyanine green.
    Tange FP, Peul RC, van den Hoven P, Koning S, et al · · 2025 · cited 2× · PMID 39777554 · DOI 10.1007/s00423-024-03589-1

Verify or expand the search:

Other trials of Near-infrared fluorescence imaging of perfusion

Trials testing the same drug.

Other Leiden University Medical Center trials

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