Clinical trial · Interventional
Fluorescence Angiography in the Assessment of DIEP Flap Perfusion
Indocyanine Green Fluorescence Angiography in the Assessment of Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fat Necrosis | — | UNRESOLVED | — |
| Vascularization | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tailoring the flap according to clinical assessment | Procedure | — | UNRESOLVED |
| Tailoring the flap according to ICG Angiography assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Clinical assessment of flap perfusion
- description
- Tailoring the flap according to clinical assessment of flap perfusion
- interventionNames
- Procedure: Tailoring the flap according to clinical assessment
- type
- EXPERIMENTAL
- label
- Angiography assessment of flap perfusion
- description
- Tailoring the flap according to ICG Angiography assessment of flap perfusion
- interventionNames
- Procedure: Tailoring the flap according to ICG Angiography assessment
Primary outcomes (2)
- measure
- Number of participants with fat necrosis as assessed by physical examination
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDVarela R, Casado-Sanchez C, Zarbakhsh S, Diez J, Hernandez-Godoy J, Landin L. Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial. Plast Reconstr Surg. 2020 Jan;145(1):1-10. doi: 10.1097/PRS.0000000000006393. PMID 31577664