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

October 25, 2017 updated by: University of Aarhus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

171

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent immediate or delayed, pedicle autologous flap breast reconstruction between 2012 and 2016 were enrolled in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention - ICG angiography
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
Device: Indocyanine green angiography
Control - clinical assessment
A control group receiving identical operations but without ICG-angiography evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at 6 months followup.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured from day 0 with 6 months followup
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.
Measured from day 0 with 6 months followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

August 31, 2017

Study Completion (ACTUAL)

September 30, 2017

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICG-angiography

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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