Reconstructive SurgeryEarly Phase 1NCT01204554
Microcirculation in Perforator Flaps. Enhancing Tissue Survival
A Early Phase 1 study testing Indocyanine green (ICG) in people with Reconstructive Surgery and Microcirculation, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Reconstructive Surgery, Microcirculation
- What is being tested?
- Indocyanine green (ICG)
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2008to Dec 2010
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients submitted to elective abdominoplasty
Who cannot join
- body mass index < 30 kg/m2
- morbidly obese
- patients with comorbidity such as diabetes
- vascular disease
- smokers
- patients < 18 years, and patients using anti-coagulant therapy
- pregnant
- severe hepatic insufficiency were excluded and a history of allergic reactions to ICG and iodide.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, Oslo, 0304
Haris Mesic, M.D, 004722118080, haris.mesic@oslo-universitetssykehus.no
Haris Mesic, M.D
About this study
The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.
Read the detailed description
Perforator flaps are increasingly used in reconstructive surgery both as pedicled and free flaps, mostly because of reduced donor site morbidity and superior aesthetic result. However, the there is still much to learn about the hemodynamic changes within these flaps.The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.
- Conditions
- Reconstructive Surgery, Microcirculation
- Being tested
- Indocyanine green (ICG)
- Keywords
- perforator flaps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green (ICG)Drug
a water-soluble dye that binds to plasma proteins and remains in the intravascular space after intravenous injection.ICG has a normal plasma half life of 3-4 min. Dosage planned is 0 .5 mg/kg dose of ICG resolved in 5 % dextrose 2 mg /ml.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pixel intensity using dynamic laser-induced-fluorescence-videoangiography
Perfusion measurements were conducted intraoperatively by assessing microcirculation using the technique of dynamic laser-induced-fluorescence-videoangiography (IC-VIEW, PULSION Medical Systems AG, Munich, Germany).
Measured: dec. 2008--des 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive SurgeryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204554
- Sponsor's protocol ID
- 08/223b.2008/3837 (REK)
- Status last verified
- Sep 2010
- First submitted
- 6 Sep 2010
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculation in Perforator Flaps. Enhancing Tissue Survival
- ClinicalTrials.gov ID
- NCT01204554
- Acronym / sponsor ID
- 08/223b.2008/3837 (REK)
- Conditions
- Reconstructive Surgery, Microcirculation
- Keywords
- perforator flaps
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 17 Sep 2010 (estimated)
- 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 aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.
Detailed description
Perforator flaps are increasingly used in reconstructive surgery both as pedicled and free flaps, mostly because of reduced donor site morbidity and superior aesthetic result. However, the there is still much to learn about the hemodynamic changes within these flaps.The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients submitted to elective abdominoplasty
Key exclusion criteria (8 listed)
- body mass index < 30 kg/m2
- morbidly obese
- patients with comorbidity such as diabetes
- vascular disease
- smokers
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 (ICG)a water-soluble dye that binds to plasma proteins and remains in the intravascular space after intravenous injection.ICG has a normal plasma half life of 3-4 min. Dosage planned is 0 .5 mg/kg dose of ICG resolved in 5 % dextrose 2 mg /ml. | Drug | – |
Primary outcome
Mean pixel intensity using dynamic laser-induced-fluorescence-videoangiography
Time frame: dec. 2008--des 2010
Perfusion measurements were conducted intraoperatively by assessing microcirculation using the technique of dynamic laser-induced-fluorescence-videoangiography (IC-VIEW, PULSION Medical Systems AG, Munich, Germany).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Indocyanine green (ICG) in people with Reconstructive Surgery and Microcirculation, run by Oslo University Hospital at 1 site in Norway.
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 8 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 17 Sep 2010. 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 Norway. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Haris Mesic, M.D (004722118080, Haris.Mesic@oslo-universitetssykehus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pixel intensity using dynamic laser-induced-fluorescence-videoangiography (time frame: dec. 2008--des 2010). 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 17 Sep 2010.