ICG Indocyanine Green in Reconstructive Surgery (ICG-R)

November 7, 2023 updated by: Caroline Driessen, Amsterdam UMC, location VUmc

Determining Critical Thresholds of Tissue Perfusion With ICG in Reconstructive Surgery

The success or failure of a reconstruction is largely related to the vascularization of the operated area. Near infrared fluorescence (also near infrared fluorescence angiography, NIR FA) with ICG administration is an innovative technique to quantify tissue perfusion. Based on the results obtained in other subspecialties, NIR fluorescence appears to be a promising way to quantify tissue perfusion in reconstructive surgery. Fluorescence research has previously been used in the context of microsurgery and breast reconstructions using implants, but structural objective determinations are lacking. Our study is successful if we are able to determine a cut off value for the absolute or relative perfusion parameters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

We include patients that undergo a surgical debridement and/or reconstruction. Each group consists of twenty patients.

The debridement groups mainly consist of post-oncologic patients who have undergone radiotherapy (1A) and trauma patients (1B).

Reconstructive groups include 2A Fasciocutaneous flaps 2B Osseous flaps 2C Muscle flaps 2D Vaginaplasties 2E Phalloplasties 2F Finger replantations

Description

Inclusion Criteria:

  • Aged 18 or older
  • Undergoing debridement and/or reconstructive surgery included in the aforementioned groups

Exclusion Criteria:

  • allergy or hypersensitivity to sodium iodide, iodine, ICG or shellfish
  • patients with hyperthyroidism and patients with autonomic thyroid adenoma
  • pregnancy or lactation
  • epilepsy
  • severe liver failure
  • renal failure with a GFR <60.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Debridement after radiotherapy
Drug: Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Debridement after trauma
Drug: Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Reconstructive surgery using a fasciocutaneous flap
Drug: Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Reconstructive surgery using a muscle flap
Drug: Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Reconstructive surgery using a osseous flap
Drug: Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Vaginaplasties
Vaginaplasties using a peritoneum flap or colon interposition
Drug: Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Phalloplasties
Drug: Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Finger replantation
Drug: Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum perfusion intensity (Normal)
Time Frame: Once during the surgery
1. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
Once during the surgery
Maximum perfusion intensity (ROI)
Time Frame: Once during the surgery
2. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
Once during the surgery
Relative Perfusion
Time Frame: Once during the surgery
Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame / Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
Once during the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: Once during the surgery
Time to reach maximum perfusion in region of interest (Tmax, sec)
Once during the surgery
Ingress
Time Frame: Once during the surgery
Rate of increase in intensity from baseline to peak intensity (Ingress, units)
Once during the surgery
Egress
Time Frame: Once during the surgery
Degree of decrease in intensity from peak to last measurement (Egress, units)
Once during the surgery
Lap Failure
Time Frame: Follow up at six weeks postoperative
Quantified as I <5%; II 5-15%, III 15-50%, IV> 50%, V complete
Follow up at six weeks postoperative
Wound infection
Time Frame: Follow up at six weeks postoperative
Defined as none, local wound treatment, antibiotics, or hospitalization.
Follow up at six weeks postoperative
Skin necrosis
Time Frame: Follow up at six weeks postoperative
Defined as none, partial thickness, and full thickness.
Follow up at six weeks postoperative
Delayed union
Time Frame: Follow up at six and twelve months postoperative
Radiologic examination (Xray or CT) concluding on the presence of delayed union after 6 months or non-union after 12 months
Follow up at six and twelve months postoperative
Relative Perfusion before and after tissue transfer
Time Frame: Twice during the surgery
Maximum perfusion intensity (Imax, units) in the same reference frame after tissue transfer / Maximum perfusion intensity (Imax, units) in a reference frame before tissue transfer
Twice during the surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amsterdam UMC, location VUmc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caroline Driessen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL74852.029.21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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