SurgeryNCT05360355
Flap Fenestration and Facial Organ Fabrication Guided by ICGA
An observational study of Surgery, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
In this retrospective study, patients with severe head and neck deformity were treated with monoblock pre-expanded prefabricated flaps for total face restoration. The opening of nostrils, oral and palpebral orifices, together with organ fabrication, were conducted under the guidance of intraoperative ICGA for… Read more about this study
- Who is it for?
- Ages 4 to 60 years
- Conditions the study is for
- Surgery
- What is being tested?
- total face reconstruction surgery and intraoperative indocyanine green angiography
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Jun 2021
- 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 4 to 60 years
- All sexes
- Child, Adult
Study population: This clinical study will include patients treated with total face restoration surgeries and intraoperative indocyanine green angiography from Jun 2018 to Jun 2021. It is estimated that about 10 patients will be enrolled in this study.
Who may be able to join
- Preoperative facial soft tissue deformities/defects of type III and IV
- Patients treated with monoblock pre-expanded prefabricated flaps for total face restoration.
- Agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent.
Who cannot join
- Patients with severe liver, kidney or lung insufficiency, and allergy to iodine products
- Patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate.
- Minor patients without legal guardian.
- Not willing to participate; informed consent form not signed.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Flap Fenestration and Facial Organ Fabrication Guided By Intraoperative Indocyanine Green Angiography in Total Facial Restoration
In this retrospective study, patients with severe head and neck deformity were treated with monoblock pre-expanded prefabricated flaps for total face restoration. The opening of nostrils, oral and palpebral orifices, together with organ fabrication, were conducted under the guidance of intraoperative ICGA for hemodynamic evaluation. The hemodynamic analysis of flap perfusion before and after fenestration. Postoperative follow-up including vascular crisis, infection, flap necrosis and patients' aesthetic and functional recovery.
Read the detailed description
The study included patients with severe head and neck deformity treated by our reconstructive team from Jun 2018 to Jun 2021, with monoblock pre-expanded flaps from the anterior chest, abdomen or back. For flap harvested from the chest, flap prefabrication was conducted in the first stage. In brief, the full length of the descending branch of the lateral circumflex femoral artery, vein and surrounding fascia were harvested and transferred as a free vascular carrier to the subcutaneous space on the anterior thoracic region. The pedicle vessels were anastomosed to the superior thyroid or facial vessels. A rectangular tissue expander was placed underneath the vascular carrier for expansion. In the second stage, the prefabricated flap was transferred to the pedicle vessel to replace the facial defects. Notably, dominant perforators were detected preoperatively and preserved during flap harvest for potential vascular anastomosis. For flaps from the abdomen and back, flaps were harvested as multi-pedicle free flaps. Exclusion criteria included severe liver, kidney or lung insufficiency, and allergy to iodine products.
Upon flap transfer to the face, a 2 mL bolus of ICG (2.5mg/mL) was administrated intravenously and the fluorescence signals were detected by a SPY imaging system (Novadaq Technologies, Inc., Canada). The course of each nourishing vessels and their respective perfusion territory were assessed. During flap fenestration, the opening of oral orifice was given the highest priority, followed by nostrils and palpebral orifices. If the region intended for flap fenestration was well perfused and did not contain major communicating branches or the penetration point of perforators, orifices would be opened directly. In the event of insufficient blood supply, additional vascular anastomosis would be considered for perfusion augmentation, and ICGA would be reconducted for evaluation.
The hemodynamic analysis of flaps was performed before and after fenestration using the incorporated SPY-Q software. The patients' aesthetic and functional recovery were evaluated, as well as postoperative complications including vascular crisis, infection, and flap necrosis.
- Conditions
- Surgery
- Being tested
- total face reconstruction surgery and intraoperative indocyanine green angiography
- Keywords
- Total facial restoration, Indocyanine green angiography, Flap fenestration, Facial organ fabrication, Flap surgery, Case series
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total face reconstruction surgery and intraoperative indocyanine green angiographyProcedure or surgery
Patients with total facial scarring following burn injury were treated with monoblock pre-expanded prefabricated flaps for total face restoration. The opening of nostrils, oral and palpebral orifices, together with organ fabrication, were conducted under the guidance of intraoperative ICGA for hemodynamic evaluation.
| Study group | Role | What they receive |
|---|---|---|
| patients undergone total face reconstruction and intraoperative indocyanine green angiography | This clinical study enrolled 10 patients treated with total face reconstruction and intraoperative indocyanine green angiography from Jun 2018 to Jun 2021. Receives: Procedure: total face reconstruction surgery and intraoperative indocyanine green angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The arterial infusion rate of flap before flap fenestration
The flap perfusion before flap fenestration was recorded by indocyanine green angiography (SPY imaging system, Novadaq Technologies Inc, Canada). The arterial infusion rate of flap perfusion before flap fenestration was calculated using the incorporated SPY-Q software.
Measured: 10 minutes
The arterial infusion rate of flap after flap fenestration
The flap perfusion after flap fenestration was recorded by indocyanine green angiography (SPY imaging system, Novadaq Technologies Inc, Canada). The arterial infusion rate of flap perfusion after flap fenestration was calculated using the incorporated SPY-Q software.
Measured: 10 minutes
Secondary outcomes (1)
The occurrence rate of flap necrosis
The occurrence rate of flap necrosis was calculated at 2 weeks postoperatively. Flap necrosis was determined by three surgeons postoperatively. Necrosis includes epidermolysis, partial/superficial necrosis, and full-thickness necrosis. Partial/superficial necrosis is defined as loss of epidermis and partial loss of dermis with no subcutaneous tissue exposure/no requirement for debridement. Full-thickness necrosis is defined as loss of both epidermis and dermis.
Measured: 2 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Jun 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
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.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zan, MD, Ph.D, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360355
- Sponsor's protocol ID
- ICGA Guided Flap Fenestration
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are only available from the corresponding author on reasonable request.
Publications
Huang X, Li H, Gu S, Gao Y, Khoong Y, Liu Y, Luo S, Gu B, Li Q, Zan T. Intraoperative Indocyanine Green Angiography Facilitates Flap Fenestration and Facial Organ Fabrication in Total Facial Restoration. Plast Reconstr Surg. 2024 Jun 1;153(6):1416-1424. doi: 10.1097/PRS.0000000000010891. Epub 2023 Jun 28.
PubMed 37382913
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flap Fenestration and Facial Organ Fabrication Guided By Intraoperative Indocyanine Green Angiography in Total Facial Restoration
- ClinicalTrials.gov ID
- NCT05360355
- Acronym / sponsor ID
- ICGA Guided Flap Fenestration
- Conditions
- Surgery
- Keywords
- Total facial restoration, Indocyanine green angiography, Flap fenestration, Facial organ fabrication, Flap surgery, Case series
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 4 May 2022 (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.
In this retrospective study, patients with severe head and neck deformity were treated with monoblock pre-expanded prefabricated flaps for total face restoration. The opening of nostrils, oral and palpebral orifices, together with organ fabrication, were conducted under the guidance of intraoperative ICGA for hemodynamic evaluation. The hemodynamic analysis of flap perfusion before and after fenestration. Postoperative follow-up including vascular crisis, infection, flap necrosis and patients' aesthetic and functional recovery.
Detailed description
The study included patients with severe head and neck deformity treated by our reconstructive team from Jun 2018 to Jun 2021, with monoblock pre-expanded flaps from the anterior chest, abdomen or back. For flap harvested from the chest, flap prefabrication was conducted in the first stage. In brief, the full length of the descending branch of the lateral circumflex femoral artery, vein and surrounding fascia were harvested and transferred as a free vascular carrier to the subcutaneous space on the anterior thoracic region. The pedicle vessels were anastomosed to the superior thyroid or facial vessels. A rectangular tissue expander was placed underneath the vascular carrier for expansion. In the second stage, the prefabricated flap was transferred to the pedicle vessel to replace the facial defects. Notably, dominant perforators were detected preoperatively and preserved during flap harvest for potential vascular anastomosis. For flaps from the abdomen and back, flaps were harvested as multi-pedicle free flaps. Exclusion criteria included severe liver, kidney or lung insufficiency, and allergy to iodine products.
Upon flap transfer to the face, a 2 mL bolus of ICG (2.5mg/mL) was administrated intravenously and the fluorescence signals were detected by a SPY imaging system (Novadaq Technologies, Inc., Canada). The course of each nourishing vessels and their respective perfusion territory were assessed. During flap fenestration, the opening of oral orifice was given the highest priority, followed by nostrils and palpebral orifices. If the region intended for flap fenestration was well perfused and did not contain major communicating branches or the penetration point of perforators, orifices would be opened directly. In the event of insufficient blood supply, additional vascular anastomosis would be considered for perfusion augmentation, and ICGA would be reconducted for evaluation.
The hemodynamic analysis of flaps was performed before and after fenestration using the incorporated SPY-Q software. The patients' aesthetic and functional recovery were evaluated, as well as postoperative complications including vascular crisis, infection, and flap necrosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergone total face reconstruction and intraoperative indocyanine green angiography | – | Procedure: total face reconstruction surgery and intraoperative indocyanine green angiographyThis clinical study enrolled 10 patients treated with total face reconstruction and intraoperative indocyanine green angiography from Jun 2018 to Jun 2021. |
Who may qualify
- Ages
- 4 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- This clinical study will include patients treated with total face restoration surgeries and intraoperative indocyanine green angiography from Jun 2018 to Jun 2021. It is estimated that about 10 patients will be enrolled in this study.
Key inclusion criteria (3 listed)
- Preoperative facial soft tissue deformities/defects of type III and IV
- Patients treated with monoblock pre-expanded prefabricated flaps for total face restoration.
- Agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent.
Key exclusion criteria (4 listed)
- Patients with severe liver, kidney or lung insufficiency, and allergy to iodine products
- Patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate.
- Minor patients without legal guardian.
- Not willing to participate; informed consent form not signed.
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 |
|---|---|---|
| total face reconstruction surgery and intraoperative indocyanine green angiographyPatients with total facial scarring following burn injury were treated with monoblock pre-expanded prefabricated flaps for total face restoration. The opening of nostrils, oral and palpebral orifices, together with organ fabrication, were conducted under the guidance of intraoperative ICGA for hemodynamic evaluation. | Procedure or surgery | patients undergone total face reconstruction and intraoperative indocyanine green angiography |
Primary outcome
The arterial infusion rate of flap before flap fenestration
Time frame: 10 minutes
The flap perfusion before flap fenestration was recorded by indocyanine green angiography (SPY imaging system, Novadaq Technologies Inc, Canada). The arterial infusion rate of flap perfusion before flap fenestration was calculated using the incorporated SPY-Q software.
The arterial infusion rate of flap after flap fenestration
Time frame: 10 minutes
The flap perfusion after flap fenestration was recorded by indocyanine green angiography (SPY imaging system, Novadaq Technologies Inc, Canada). The arterial infusion rate of flap perfusion after flap fenestration was calculated using the incorporated SPY-Q software.
1 secondary outcome
The occurrence rate of flap necrosis
Time frame: 2 weeks post-operation
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 4 May 2022.
- Derived from this study: PubMed 37382913Huang X, Li H, Gu S, Gao Y, Khoong Y, Liu Y, Luo S, Gu B, Li Q, Zan T. Intraoperative Indocyanine Green Angiography Facilitates Flap Fenestration and Facial Organ Fabrication in Total Facial Restoration. Plast Reconstr Surg. 2024 Jun 1;153(6):1416-1424. doi: 10.1097/PRS.0000000000010891. Epub 2023 Jun 28.
- Individual participant dataSharing planned: No. Individual participant data are only available from the corresponding author on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 3 inclusion and 4 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 4 May 2022. 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 China. 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?
The arterial infusion rate of flap before flap fenestration (time frame: 10 minutes). The study lists 2 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 NCT05360355, 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 4 May 2022.