Free FlapNCT06313385
Investigating the Impact of Indocyanine Green Titration on Fluorescent Intensity in Free Flap : An Exploration of Alternative Indicators
A study testing Indocyanine Green Fluorescence (ICG), Temperature and Transcutaneous oxygen and carbon dioxide pressure in people with Free Flap and Indocyanine Green, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Free Flap, Indocyanine Green, Microsurgery
- What is being tested?
- Indocyanine Green Fluorescence (ICG), Temperature and Transcutaneous oxygen and carbon dioxide pressure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 29 Mar 2024
- 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
- Free flap operation that being performed by researchers.
- Free Flap must have a skin paddle located on the body skin area with intraoperative ischemic time of at least 60 Minutes
- Free flap should be in a viable/vital condition judged from the clinical examination of the flap, which includes color, temperature, turgor, capillary refill time (CRT), and skin prick test, immediately post surgery
- Body area that will be a flap-free donor area has no history of trauma or operation
- Patient with blood albumin value >3 gr / dL
- The patient/family sign the informed consent sheet stating willingness to become research sample
Who cannot join
- Patients have increased sensitivity to iodine or ICG
- Free Flaps that being transported undergo trauma or damage due to external factors during treatment
- Patient with high urea and creatinine level
- Patient with high Alanine transaminase (ALT) and Aspartate transaminase (AST) level
- Patients who receive injectable heparin treatment containing natrium disulfite preoperatively
- Patients who regularly take anti-seizure drugs, haloperidol, heroin, meperidine, Metamizole, methadone, morphine, nitrofurantoin, opium, phenobarbital, and phenylbutazone.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: The Effect of Indocyanine Green Titration on Fluorescent Intensity Degree in Free Flap : A Lookout to Flap Surface Temperature, TCPO2, TCPCO2, HIF-1 Alpha Expression Level, and Histopathology
This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. In addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (TcPCO2), transcutaneous pressure of oxygen (TcPCO2), HIF - 1 alpha expression, and flap histopathology morphology to the intensity degree of ICG fluorescence imaging results with titrated doses.
Read the detailed description
The ICG contrast solution will be evaluated with Near-Infrared (NIR) camera that being fixated 20 cm above the flap after the injection. The imaging result will be analyzed using ImageJ Application to assess the grey value. The fluorescent intensity of ICG will be compared with other tests.
Drop Out Criteria :
- Patients who are unable to complete the research procedure due to various condition, such as death
- Patients who experience complications or worsening, during and after surgery.
- Conditions
- Free Flap, Indocyanine Green, Microsurgery, Temperature Change, Body
- Being tested
- Indocyanine Green Fluorescence (ICG), Temperature, Transcutaneous oxygen and carbon dioxide pressure, Histopathology, Hypoxia inducible factor-1 (HIF-1) alpha
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green Fluorescence (ICG)Diagnostic test
Also called ICG fluorescence
The ICG will be injected intravenously and being assessed with Near-infrared (NIR) camera FLUORO4000XL 20 cm above the flap and fluorescence intensity counted with application called ImageJ
TemperatureDiagnostic test
Portable thermal imaging camera called Forward-looking infrared (FLIR) ONE® was used to assess flap and normal skin temperature. The FLIR ONE® device was place in perpendicular manner from the skin. The images were attained in two points of times which is direct temperature and after cold challenge test.
Transcutaneous oxygen and carbon dioxide pressureDiagnostic test
The partial transcutaneous pressure is measured in flap using transcutaneous monitor (TCM) Combi probe. The probe should be cleaned using alcohol pads before use. After 5-10 minutes, the TCM 4 machine monitor should show stable transcutaneous oxygen and carbon dioxide pressure from the flap
HistopathologyDiagnostic test
A part of tissue from free flap is acquired and stored in 10% formalin tube. Later on, the tissue was colored with hematoxylin-eosin, neutrophile count, necrosis volume, and vessel proliferation will be assessed
Hypoxia inducible factor-1 (HIF-1) alphaDiagnostic test
Peripheral tissue from distal free flap (0,5 x 0,5 cm in size) is obtained and stored in tube with dry ice. The tissue is assessed with human HIF - 1 Alpha Enzyme-Linked Immunosorbent Assay (ELISA) kit ab171577.
| Study group | Role | What they receive |
|---|---|---|
| Group 5 mg/mL | Experimental | This group received 5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 1 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. Receives: Diagnostic Test: Indocyanine Green Fluorescence (ICG); Diagnostic Test: Temperature; Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure; Diagnostic Test: Histopathology; Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alpha |
| Group 2,5 mg/mL | Active comparator | This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,5 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,5 mL Dextrose 5%. Receives: Diagnostic Test: Indocyanine Green Fluorescence (ICG); Diagnostic Test: Temperature; Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure; Diagnostic Test: Histopathology; Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alpha |
| Group 0,5 mg/mL | Active comparator | This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,1 mL ICG is taken using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,9 mL Dextrose 5%. Receives: Diagnostic Test: Indocyanine Green Fluorescence (ICG); Diagnostic Test: Temperature; Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure; Diagnostic Test: Histopathology; Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion
The fluorescence of ICG that being captured with near-infrared (NIR) camera is store in video file to be evaluated. The video duration is 2 minutes long after ICG injection. The fluorescence intensity of the flap in the video is being measured with ImageJ application. The highest level of intensity (numerical data) is considered as the optimal fluorescence intensity that being analyzed later on. The optimal indocyanine green titration will be seen after ImageJ analysis in numerical data called gray values.
Measured: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Secondary outcomes (6)
The ICG fluorescence intensity in different titration dose with flap surface Temperature
The surface temperature of the flap and the surrounding normal tissue is being measured with mobile thermal camera. The temperature result is shown in celsius degree
Measured: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure
The transcutaneous carbon dioxide and oxygen pressure are shown in mmHg after being measured with transcutaneous (TCM) Combi 4 device.
Measured: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count
The neutrophile count is shown as cells per high power field. The high power field in this study is 20x optical view magnification in microscope. This is part of histopathology examination.
Measured: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume
The necrosis volume result is shown in numerical data percentage (%). High power field which is 20x optical view magnification in microscope. This is part of histopathology examination.
Measured: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue
The vascular flap proliferation can be seen using after the tissue sample is stained immunohistochemically using cluster of differentiation (CD) 31 marker in 20x optical view magnification using microscope. The result will be seen in numerical data. This is part of histopathology examination.
Measured: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha
The ICG fluorescence intensity in 3 different titration dose will be compared with HIF-1 Alpha. The HIF-1 Alpha will be shown as numerical value in ng/mg of proteins.
Measured: Intraoperative (before start of anastomosis and before end of anastomosis time), 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jan 2023
- Primary completion29 Mar 2024 (estimated)
- Study completion29 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free FlapStudies 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
- Sequential
- Model description
- The population were divided into three equal groups of indocyanine green concentration : 5 milligram per milliliter (mg/mL), 2,5 mg/mL, and 0,5 mg/mL
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parintosa Atmodiwirjo, Universitas Indonesia
- Investigators
- Parintosa Atmodiwirjo, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313385
- Sponsor's protocol ID
- 22-10-1180
- Status last verified
- Mar 2024
- First submitted
- 15 Jan 2024
- Last updated
- 15 Mar 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Indocyanine Green Titration on Fluorescent Intensity Degree in Free Flap : A Lookout to Flap Surface Temperature, TCPO2, TCPCO2, HIF-1 Alpha Expression Level, and Histopathology
- ClinicalTrials.gov ID
- NCT06313385
- Acronym / sponsor ID
- 22-10-1180
- Conditions
- Free Flap, Indocyanine Green, Microsurgery, Temperature Change, Body
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 29 Mar 2024 (estimated)
- Study completion
- 29 Mar 2024 (estimated)
- First posted
- 15 Mar 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.
This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. In addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (TcPCO2), transcutaneous pressure of oxygen (TcPCO2), HIF - 1 alpha expression, and flap histopathology morphology to the intensity degree of ICG fluorescence imaging results with titrated doses.
Detailed description
The ICG contrast solution will be evaluated with Near-Infrared (NIR) camera that being fixated 20 cm above the flap after the injection. The imaging result will be analyzed using ImageJ Application to assess the grey value. The fluorescent intensity of ICG will be compared with other tests.
Drop Out Criteria :
- Patients who are unable to complete the research procedure due to various condition, such as death
- Patients who experience complications or worsening, during and after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 milligram per milliliter (mg/mL), 2,5 mg/mL, and 0,5 mg/mL
| Arm | Type | Receives |
|---|---|---|
| Group 5 mg/mL | Experimental | Diagnostic Test: Indocyanine Green Fluorescence (ICG), Diagnostic Test: Temperature, Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure, Diagnostic Test: Histopathology, Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alphaThis group received 5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 1 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. |
| Group 2,5 mg/mL | Active comparator | Diagnostic Test: Indocyanine Green Fluorescence (ICG), Diagnostic Test: Temperature, Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure, Diagnostic Test: Histopathology, Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alphaThis group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,5 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,5 mL Dextrose 5%. |
| Group 0,5 mg/mL | Active comparator | Diagnostic Test: Indocyanine Green Fluorescence (ICG), Diagnostic Test: Temperature, Diagnostic Test: Transcutaneous oxygen and carbon dioxide pressure, Diagnostic Test: Histopathology, Diagnostic Test: Hypoxia inducible factor-1 (HIF-1) alphaThis group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,1 mL ICG is taken using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,9 mL Dextrose 5%. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Free flap operation that being performed by researchers.
- Free Flap must have a skin paddle located on the body skin area with intraoperative ischemic time of at least 60 Minutes
- Free flap should be in a viable/vital condition judged from the clinical examination of the flap, which includes color, temperature, turgor, capillary refill time (CRT), and skin prick test, immediately post surgery
- Body area that will be a flap-free donor area has no history of trauma or operation
- Patient with blood albumin value >3 gr / dL
Key exclusion criteria (6 listed)
- Patients have increased sensitivity to iodine or ICG
- Free Flaps that being transported undergo trauma or damage due to external factors during treatment
- Patient with high urea and creatinine level
- Patient with high Alanine transaminase (ALT) and Aspartate transaminase (AST) level
- Patients who receive injectable heparin treatment containing natrium disulfite preoperatively
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 Green Fluorescence (ICG)Also: ICG fluorescenceThe ICG will be injected intravenously and being assessed with Near-infrared (NIR) camera FLUORO4000XL 20 cm above the flap and fluorescence intensity counted with application called ImageJ | Diagnostic test | Group 0,5 mg/mL, Group 2,5 mg/mL, Group 5 mg/mL |
| TemperaturePortable thermal imaging camera called Forward-looking infrared (FLIR) ONE® was used to assess flap and normal skin temperature. The FLIR ONE® device was place in perpendicular manner from the skin. The images were attained in two points of times which is direct temperature and after cold challenge test. | Diagnostic test | Group 0,5 mg/mL, Group 2,5 mg/mL, Group 5 mg/mL |
| Transcutaneous oxygen and carbon dioxide pressureThe partial transcutaneous pressure is measured in flap using transcutaneous monitor (TCM) Combi probe. The probe should be cleaned using alcohol pads before use. After 5-10 minutes, the TCM 4 machine monitor should show stable transcutaneous oxygen and carbon dioxide pressure from the flap | Diagnostic test | Group 0,5 mg/mL, Group 2,5 mg/mL, Group 5 mg/mL |
| HistopathologyA part of tissue from free flap is acquired and stored in 10% formalin tube. Later on, the tissue was colored with hematoxylin-eosin, neutrophile count, necrosis volume, and vessel proliferation will be assessed | Diagnostic test | Group 0,5 mg/mL, Group 2,5 mg/mL, Group 5 mg/mL |
| Hypoxia inducible factor-1 (HIF-1) alphaPeripheral tissue from distal free flap (0,5 x 0,5 cm in size) is obtained and stored in tube with dry ice. The tissue is assessed with human HIF - 1 Alpha Enzyme-Linked Immunosorbent Assay (ELISA) kit ab171577. | Diagnostic test | Group 0,5 mg/mL, Group 2,5 mg/mL, Group 5 mg/mL |
Primary outcome
The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion
Time frame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
The fluorescence of ICG that being captured with near-infrared (NIR) camera is store in video file to be evaluated. The video duration is 2 minutes long after ICG injection. The fluorescence intensity of the flap in the video is being measured with ImageJ application. The highest level of intensity (numerical data) is considered as the optimal fluorescence intensity that being analyzed later on. The optimal indocyanine green titration will be seen after ImageJ analysis in numerical data called gray values.
6 secondary outcomes
The ICG fluorescence intensity in different titration dose with flap surface Temperature
Time frame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure
Time frame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count
Time frame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume
Time frame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue
Time frame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha
Time frame: Intraoperative (before start of anastomosis and before end of anastomosis time), 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 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 principal investigator
Fakultas Kedokteran 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 Fluorescence (ICG), Temperature and Transcutaneous oxygen and carbon dioxide pressure in people with Free Flap and Indocyanine Green, 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 6 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 15 Mar 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?
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?
The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion (time frame: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery). 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 15 Mar 2024.