Study Results
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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ENROLLING_BY_INVITATION
160 participants
OBSERVATIONAL
2023-05-09
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Debridement after radiotherapy
Debridement after radiotherapy
Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Debridement after trauma
Debridement after trauma
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
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
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
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
Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Phalloplasties
Phalloplasties
Indocyanine green
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
Finger replantation
Finger replantation
Indocyanine green
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
Eligibility Criteria
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Inclusion Criteria
* Undergoing debridement and/or reconstructive surgery included in the aforementioned groups
Exclusion Criteria
* patients with hyperthyroidism and patients with autonomic thyroid adenoma
* pregnancy or lactation
* epilepsy
* severe liver failure
* renal failure with a GFR \<60.
18 Years
110 Years
ALL
Yes
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Responsible Party
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Caroline Driessen
Plastic Surgeon
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
Countries
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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.
Other Identifiers
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NL74852.029.21
Identifier Type: -
Identifier Source: org_study_id
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