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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03069261

Enrollment

171

Registered

2017-03-03

Start date

2016-08-01

Completion date

2017-09-30

Last updated

2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast reconstruction, Autologous tissue flaps, Indocyanine green angiography, Breast cancer

Brief summary

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.

Detailed description

ICG-angiography is a real-time visualization of tissue perfusion using intravenous fluorescence. It allows the surgeon a tool for intraoperatively assessment of tissue perfusion of the autologous flap, providing a basis for trimming of hypo perfused areas. The study evaluates the effect of inclusion of this technique by examine postoperative outcomes retrospectively. This is done by differentiation between major and minor complications to evaluate the greatest gains of the intervention.

Interventions

DEVICEIndocyanine green angiography

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Major complications	Measured at 6 months followup.	Major complications included necrosis of most of the flap (2/3), total flap loss and surgical evacuated hematoma.

Secondary

Measure	Time frame	Description
Minor complications	Measured from day 0 with 6 months followup	A minor complication included clinical sign of infection, prolonged wound healing (defined as prolonged healing time requiring dressing changes assisted by health personnel), fat necrosis and skin necrosis.
Timing of reconstruction	Measured from day 0 with 6 months followup	Comparison of the timing of the reconstruction with the complication rate, comparing immediate reconstructions with delayed reconstructions.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026