Free Flap EvaluationNCT06220357
Diluted Indocyanine Green Angiography: a Novel Approach to Free Flap Perfusion Evaluation in Reconstructive Microsurgery
A study testing Indocyanine Green in people with Free Flap Evaluation and Indocyanine Green Concentration, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The evaluation of perfusion in free flaps is crucial in clinical practice. Currently, the gold standard for evaluation is subjective through clinical assessment. However, indocyanine green angiography (ICGA), a tool that uses a near-infrared (NIR) camera to depict and monitor flap vascularization, offers an objective… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Free Flap Evaluation, Indocyanine Green Concentration, Perfusion
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Oct 2022to 10 Oct 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- individuals who have successfully undergone micro-reconstruction surgery utilizing a viable free flap, with no prior surgical intervention in the area under evaluation, and the donor area for the free flap is devoid of any history of trauma or surgery. Furthermore, these subjects exhibit an albumin level exceeding 3 g/dL, Haemoglobin more than 10mg/dL, and no complication intraoperative
Who cannot join
- patients with a history of allergy or hypersensitivity to iodine or ICG, those with renal insufficiency or undergoing routine hemodialysis, and those regularly consuming sodium bisulfites. Additionally, patients with hepatic dysfunction, those regularly taking anticonvulsant drugs, and those experiencing complications during and post-operation are also excluded. Furthermore, patients with psychopathology and/or mental disorders, and those whose transferred free flap has experienced trauma or damage due to external factors during care are not suitable for this study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Comparing Diluted to Standard Concentration Indocyanine Green Angiography: a Novel Approach to Free Flap Perfusion Evaluation in Reconstructive Microsurgery
The evaluation of perfusion in free flaps is crucial in clinical practice. Currently, the gold standard for evaluation is subjective through clinical assessment. However, indocyanine green angiography (ICGA), a tool that uses a near-infrared (NIR) camera to depict and monitor flap vascularization, offers an objective and reproducible alternative. The population in this study were divided into three equal groups, where each groups were assessed with Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). The study was conducted with three distinct concentrations of ICGA: 5 mg/mL (100% standard concentration), 2.5 mg/mL (50%), and 0.5 mg/mL (10%). Indocyanine green was given in immediate postoperative manner, after the patient defect has been reconstructed with free flap.
Read the detailed description
Indocyanine green (ICG) angiography is a novel technique for assessing tissue perfusion. The primary outcome is gray values that being evaluated with IMAGE. Through this study optimal concentration that will show fluorescence in NIR camera can be seen. This is important in order to evaluate free flap perfusion.
This study included 47 patients who underwent free flap surgery. The subjects were consisted of postoperative patient with fibular free flap (FFF), anterolateral thigh flap (ALT), radial forearm free flap (RFFF), and deep inferior epigastric perforator flap (DIEP), with inclusion criteria of this study are individuals who have successfully undergone micro-reconstruction surgery utilizing a viable free flap, with no prior surgical intervention in the area under evaluation, and the donor area for the free flap is devoid of any history of trauma or surgery.
- Being tested
- Indocyanine Green
- Keywords
- Free flap, Indocyanine Green Reconstructive, Microsurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDiagnostic test
The patients were split into three different groups, the patient were given ICG with three different concentrations in a double-blind randomized manner postoperatively. The fluorescence emitted was quantitatively analyzed using the ImageJ software to ascertain the mean gray values, providing a robust measure of the ICGA concentration. The imaging was captured using a FLUORO 4000XL type NIR camera, positioned at a distance of 15-20 cm perpendicular to the flap.
| Study group | Role | What they receive |
|---|---|---|
| Group A (5 mg/mL) | Experimental | This group received 5 mg/mL of ICG or 100% in terms of concentration. The 1 mL of the ICG solution was taken using a 3 mL syringe Receives: Diagnostic Test: Indocyanine Green |
| Group B (2,5 mg/mL) | Active comparator | This group received 2,5 mg/mL of ICG or 50% in terms of concentration. The 0.5 mL of the ICG solution was mixed with 0.5 mL of distilled water using a 1 cc syringe Receives: Diagnostic Test: Indocyanine Green |
| Group C (0,5 mg/mL) | Active comparator | This group received 0,5 mg/mL of ICG or 10% in terms of concentration. The 0.1 mL of the ICG solution was mixed with 0.9 mL of distilled water using a 1 cc syringe Receives: Diagnostic Test: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gray value of indocyanine green fluorescent
The gray values were seen as the primary outcome to found which concentration has the best fluorescence outcome. NIR Camera, 20 cm above the flap, will assess the fluorescence due to contrast. All groups results are being evaluated with IMAGEJ to produce gray value.
Measured: 2-5 minutes after the ICG injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start10 Oct 2022
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Flap EvaluationStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The population were divided into three equal groups of indocyanine green concentration : 5 mg/mL, 2,5 mg/mL, and 0,5 mg/mL
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parintosa Atmodiwirjo, Universitas Indonesia
- Investigators
- Parintosa Atmodiwirjo, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220357
- Sponsor's protocol ID
- 22-06-0636
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Diluted to Standard Concentration Indocyanine Green Angiography: a Novel Approach to Free Flap Perfusion Evaluation in Reconstructive Microsurgery
- ClinicalTrials.gov ID
- NCT06220357
- Acronym / sponsor ID
- 22-06-0636
- Keywords
- Free flap, Indocyanine Green Reconstructive, Microsurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 23 Jan 2024 (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 evaluation of perfusion in free flaps is crucial in clinical practice. Currently, the gold standard for evaluation is subjective through clinical assessment. However, indocyanine green angiography (ICGA), a tool that uses a near-infrared (NIR) camera to depict and monitor flap vascularization, offers an objective and reproducible alternative. The population in this study were divided into three equal groups, where each groups were assessed with Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). The study was conducted with three distinct concentrations of ICGA: 5 mg/mL (100% standard concentration), 2.5 mg/mL (50%), and 0.5 mg/mL (10%). Indocyanine green was given in immediate postoperative manner, after the patient defect has been reconstructed with free flap.
Detailed description
Indocyanine green (ICG) angiography is a novel technique for assessing tissue perfusion. The primary outcome is gray values that being evaluated with IMAGE. Through this study optimal concentration that will show fluorescence in NIR camera can be seen. This is important in order to evaluate free flap perfusion.
This study included 47 patients who underwent free flap surgery. The subjects were consisted of postoperative patient with fibular free flap (FFF), anterolateral thigh flap (ALT), radial forearm free flap (RFFF), and deep inferior epigastric perforator flap (DIEP), with inclusion criteria of this study are individuals who have successfully undergone micro-reconstruction surgery utilizing a viable free flap, with no prior surgical intervention in the area under evaluation, and the donor area for the free flap is devoid of any history of trauma or surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The population were divided into three equal groups of indocyanine green concentration : 5 mg/mL, 2,5 mg/mL, and 0,5 mg/mL
| Arm | Type | Receives |
|---|---|---|
| Group A (5 mg/mL) | Experimental | Diagnostic Test: Indocyanine GreenThis group received 5 mg/mL of ICG or 100% in terms of concentration. The 1 mL of the ICG solution was taken using a 3 mL syringe |
| Group B (2,5 mg/mL) | Active comparator | Diagnostic Test: Indocyanine GreenThis group received 2,5 mg/mL of ICG or 50% in terms of concentration. The 0.5 mL of the ICG solution was mixed with 0.5 mL of distilled water using a 1 cc syringe |
| Group C (0,5 mg/mL) | Active comparator | Diagnostic Test: Indocyanine GreenThis group received 0,5 mg/mL of ICG or 10% in terms of concentration. The 0.1 mL of the ICG solution was mixed with 0.9 mL of distilled water using a 1 cc syringe |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- individuals who have successfully undergone micro-reconstruction surgery utilizing a viable free flap, with no prior surgical intervention in the area under evaluation, and the donor area for the free flap is devoid of any history of trauma or surgery. Furthermore, these subjects exhibit an albumin level exceeding 3 g/dL, Haemoglobin more than 10mg/dL, and no complication intraoperative
Key exclusion criteria (1 listed)
- patients with a history of allergy or hypersensitivity to iodine or ICG, those with renal insufficiency or undergoing routine hemodialysis, and those regularly consuming sodium bisulfites. Additionally, patients with hepatic dysfunction, those regularly taking anticonvulsant drugs, and those experiencing complications during and post-operation are also excluded. Furthermore, patients with psychopathology and/or mental disorders, and those whose transferred free flap has experienced trauma or damage due to external factors during care are not suitable for this study
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 GreenThe patients were split into three different groups, the patient were given ICG with three different concentrations in a double-blind randomized manner postoperatively. The fluorescence emitted was quantitatively analyzed using the ImageJ software to ascertain the mean gray values, providing a robust measure of the ICGA concentration. The imaging was captured using a FLUORO 4000XL type NIR camera, positioned at a distance of 15-20 cm perpendicular to the flap. | Diagnostic test | Group A (5 mg/mL), Group B (2,5 mg/mL), Group C (0,5 mg/mL) |
Primary outcome
Gray value of indocyanine green fluorescent
Time frame: 2-5 minutes after the ICG injection
The gray values were seen as the primary outcome to found which concentration has the best fluorescence outcome. NIR Camera, 20 cm above the flap, will assess the fluorescence due to contrast. All groups results are being evaluated with IMAGEJ to produce gray value.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Parintosa Atmodiwirjo, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green in people with Free Flap Evaluation and Indocyanine Green Concentration, run by Universitas Indonesia at 1 site in Indonesia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jan 2024. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gray value of indocyanine green fluorescent (time frame: 2-5 minutes after the ICG injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2024.