SurgeryICG-RNCT06129669
ICG Indocyanine Green in Reconstructive Surgery
An observational study of Surgery and Fluorescence, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery, Fluorescence
- What is being tested?
- Indocyanine green
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 May 2023to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Aged 18 or older
- Undergoing debridement and/or reconstructive surgery included in the aforementioned groups
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Surgery, Fluorescence
- Being tested
- Indocyanine green
- Keywords
- Reconstructive surgery, Free flap, Pedicled flap, Debridement, Fluorescence imaging, Indocyanine green
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Administration of ICG during surgery and recording of the fluorescence video to perform data analyses
| Study group | Role | What they receive |
|---|---|---|
| Debridement after radiotherapy | Debridement after radiotherapy Receives: Drug: Indocyanine green | |
| Debridement after trauma | Debridement after trauma Receives: Drug: Indocyanine green | |
| Reconstructive surgery using a fasciocutaneous flap | Reconstructive surgery using a fasciocutaneous flap Receives: Drug: Indocyanine green | |
| Reconstructive surgery using a muscle flap | Reconstructive surgery using a muscle flap Receives: Drug: Indocyanine green | |
| Reconstructive surgery using a osseous flap | Reconstructive surgery using a osseous flap Receives: Drug: Indocyanine green | |
| Vaginaplasties | Vaginaplasties using a peritoneum flap or colon interposition Receives: Drug: Indocyanine green | |
| Phalloplasties | Phalloplasties Receives: Drug: Indocyanine green | |
| Finger replantation | Finger replantation Receives: Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum perfusion intensity (Normal)
- Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
Measured: Once during the surgery
Maximum perfusion intensity (ROI)
- Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
Measured: 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
Measured: Once during the surgery
Secondary outcomes (8)
Tmax
Time to reach maximum perfusion in region of interest (Tmax, sec)
Measured: Once during the surgery
Ingress
Rate of increase in intensity from baseline to peak intensity (Ingress, units)
Measured: Once during the surgery
Egress
Degree of decrease in intensity from peak to last measurement (Egress, units)
Measured: Once during the surgery
Lap Failure
Quantified as I <5%; II 5-15%, III 15-50%, IV> 50%, V complete
Measured: Follow up at six weeks postoperative
Wound infection
Defined as none, local wound treatment, antibiotics, or hospitalization.
Measured: Follow up at six weeks postoperative
Skin necrosis
Defined as none, partial thickness, and full thickness.
Measured: 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
Measured: 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
Measured: Twice during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start9 May 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Driessen, Amsterdam UMC, location VUmc
- Investigators
- Caroline Driessen, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129669
- Sponsor's protocol ID
- NL74852.029.21
- Acronym
- ICG-R
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40387116
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Critical Thresholds of Tissue Perfusion With ICG in Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT06129669
- Acronym / sponsor ID
- ICG-R / NL74852.029.21
- Conditions
- Surgery, Fluorescence
- Keywords
- Reconstructive surgery, Free flap, Pedicled flap, Debridement, Fluorescence imaging, Indocyanine green
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Debridement after radiotherapy | – | Drug: Indocyanine greenDebridement after radiotherapy |
| Debridement after trauma | – | Drug: Indocyanine greenDebridement after trauma |
| Reconstructive surgery using a fasciocutaneous flap | – | Drug: Indocyanine greenReconstructive surgery using a fasciocutaneous flap |
| Reconstructive surgery using a muscle flap | – | Drug: Indocyanine greenReconstructive surgery using a muscle flap |
| Reconstructive surgery using a osseous flap | – | Drug: Indocyanine greenReconstructive surgery using a osseous flap |
| Vaginaplasties | – | Drug: Indocyanine greenVaginaplasties using a peritoneum flap or colon interposition |
| Phalloplasties | – | Drug: Indocyanine greenPhalloplasties |
| Finger replantation | – | Drug: Indocyanine greenFinger replantation |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Aged 18 or older
- Undergoing debridement and/or reconstructive surgery included in the aforementioned groups
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine greenAdministration of ICG during surgery and recording of the fluorescence video to perform data analyses | Drug | Debridement after radiotherapy, Debridement after trauma, Finger replantation, Phalloplasties, Reconstructive surgery using a fasciocutaneous flap, Reconstructive surgery using a muscle flap, Reconstructive surgery using a osseous flap, Vaginaplasties |
Primary outcome
Maximum perfusion intensity (Normal)
Time frame: Once during the surgery
1. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
Maximum perfusion intensity (ROI)
Time frame: Once during the surgery
2. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame
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
8 secondary outcomes
Tmax
Time frame: Once during the surgery
Ingress
Time frame: Once during the surgery
Egress
Time frame: Once during the surgery
Lap Failure
Time frame: Follow up at six weeks postoperative
Wound infection
Time frame: Follow up at six weeks postoperative
Skin necrosis
Time frame: Follow up at six weeks postoperative
Delayed union
Time frame: Follow up at six and twelve months postoperative
Relative Perfusion before and after tissue transfer
Time frame: Twice during the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 40387116Van '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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Driessen principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Fluorescence, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum perfusion intensity (Normal) (time frame: Once during the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06129669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.