ICG Indocyanine Green in Reconstructive Surgery

NCT ID: NCT06129669

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-09

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery Fluorescence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Debridement after radiotherapy

Debridement after radiotherapy

Indocyanine green

Intervention Type DRUG

Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Debridement after trauma

Debridement after trauma

Indocyanine green

Intervention Type DRUG

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

Indocyanine green

Intervention Type DRUG

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

Indocyanine green

Intervention Type DRUG

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

Indocyanine green

Intervention Type DRUG

Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Vaginaplasties

Vaginaplasties using a peritoneum flap or colon interposition

Indocyanine green

Intervention Type DRUG

Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Phalloplasties

Phalloplasties

Indocyanine green

Intervention Type DRUG

Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Finger replantation

Finger replantation

Indocyanine green

Intervention Type DRUG

Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Interventions

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Indocyanine green

Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Caroline Driessen

Plastic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caroline Driessen

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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Amsterdam UMC

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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Van 't Hof LWP, Koster ITS, Van den Elzen RM, Bouman MB, Botman M, Driessen C. Quantitative Perfusion Assessment Using Indocyanine Green in Lower Extremity Perforator Flaps. Surg Innov. 2025 Oct;32(5):435-441. doi: 10.1177/15533506251339929. Epub 2025 May 19.

Reference Type DERIVED
PMID: 40387116 (View on PubMed)

Other Identifiers

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NL74852.029.21

Identifier Type: -

Identifier Source: org_study_id

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