Clinical trial · Observational
Intraoperative Indocyanine Green Laser Angiography; Postoperative Outcomes for Autologous Tissue Flaps
Intraoperative Indocyanine Green Laser (ICG) Angiography; Evaluation of Postoperative Outcomes for Breast Reconstruction With Autologous Tissue Flaps
NCT03069261CI-TRIAL-00030071completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to identify and compare complication rates between autologous breast reconstruction techniques with and without the inclusion on intraoperative indocyanine green (ICG) angiography.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green angiography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Intervention - ICG angiography
- description
- ICG-angiography was used intraoperatively after placement of the flap at the recipient cite, evaluating the viability and perfusion of the flap. Poor perfused areas were excised
- interventionNames
- Device: Indocyanine green angiography
- label
- Control - clinical assessment
- description
- A control group receiving identical operations but without ICG-angiography evaluation.
Primary outcomes (1)
- measure
- Major complications
- timeFrame
- Measured at 6 months followup.
- description
- Major complications included necrosis of most of the flap (2/3), total flap loss and surgical evacuated hematoma.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible patients over the age of 18 years * Deemed suitable for breast reconstruction with the latissimus dorsi (LD) myocutaneous flap, muscle sparring LD flap or transverse rectus abdominal muscle (TRAM) flap Exclusion Criteria: * Patients with recurrence of breast cancer * Smoking 4 weeks prior of operation * Not able to read and understand Danish
References
Publications (0)
Data not yet available
No reference posted for this study.