ICG Indocyanine Green in Reconstructive Surgery (ICG-R)

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: Enrolling by invitation
• Conditions: Surgery; Fluorescence
• Intervention / Treatment: Drug: Indocyanine green

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Maximum perfusion intensity (Normal)	1. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame	Once during the surgery
Maximum perfusion intensity (ROI)	2. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame	Once during the surgery
Relative Perfusion	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

Outcome Measure	Measure Description	Time Frame
Tmax	Time to reach maximum perfusion in region of interest (Tmax, sec)	Once during the surgery
Ingress	Rate of increase in intensity from baseline to peak intensity (Ingress, units)	Once during the surgery
Egress	Degree of decrease in intensity from peak to last measurement (Egress, units)	Once during the surgery
Lap Failure	Quantified as I <5%; II 5-15%, III 15-50%, IV> 50%, V complete	Follow up at six weeks postoperative
Wound infection	Defined as none, local wound treatment, antibiotics, or hospitalization.	Follow up at six weeks postoperative
Skin necrosis	Defined as none, partial thickness, and full thickness.	Follow up at six weeks postoperative
Delayed union	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	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

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Caroline Driessen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Indocyanine green; Debridement; Reconstructive surgery; Fluorescence imaging; Free flap; Pedicled flap
• Other Study ID 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