Skip to main content
OpenTrials
Completed

NCT Number: NCT03069261

Intraoperative Indocyanine Green Laser Angiography; Postoperative Outcomes for Autologous Tissue Flaps

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green angiography

Device

Primary outcomes

  1. Major complications

    Time frame: Measured at 6 months followup.

    Major complications included necrosis of most of the flap (2/3), total flap loss and surgical evacuated hematoma.

Secondary outcomes

  1. Minor complications

    Time frame: 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.

  2. Timing of reconstruction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Intraoperative Indocyanine Green Laser (ICG) Angiography; Evaluation of Postoperative Outcomes for Breast Reconstruction With Autologous Tissue Flaps

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2017
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.