ICG-R: ICG Indocyanine Green in Reconstructive Surgery

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06129669

Collaborator

(none)

160

Enrollment

Location

23.8

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Fluorescence	Drug: Indocyanine green

Study Design

Study Type:

Observational

Anticipated Enrollment :

160 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Determining Critical Thresholds of Tissue Perfusion With ICG in Reconstructive Surgery

Actual Study Start Date :

May 9, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Debridement after radiotherapy Debridement after radiotherapy	Drug: Indocyanine green Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Debridement after trauma 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 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 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 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 Phalloplasties	Drug: Indocyanine green Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Finger replantation Finger replantation	Drug: Indocyanine green Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Outcome Measures

Primary Outcome Measures

Maximum perfusion intensity (Normal) [Once during the surgery]
1. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
Maximum perfusion intensity (ROI) [Once during the surgery]
2. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
Relative Perfusion [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amsterdam UMC	Amsterdam		Netherlands

Sponsors and Collaborators

Amsterdam UMC, location VUmc

Investigators

Principal Investigator: Caroline Driessen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Caroline Driessen, Plastic Surgeon, Amsterdam UMC, location VUmc

ClinicalTrials.gov Identifier:

NCT06129669

Other Study ID Numbers:

NL74852.029.21

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Caroline Driessen, Plastic Surgeon, Amsterdam UMC, location VUmc

Reconstructive surgery

Study Results

No Results Posted as of Nov 13, 2023