Clinical trial NCT05360355: Flap Fenestration and Facial Organ Fabrication Guided by ICGA
Official title: Flap Fenestration and Facial Organ Fabrication Guided By Intraoperative Indocyanine Green Angiography in Total Facial Restoration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Total facial restoration, Indocyanine green angiography, Flap fenestration, Facial organ fabrication, Flap surgery, Case series
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 10
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Preoperative facial soft tissue deformities/defects of type III and IV
2. Patients treated with monoblock pre-expanded prefabricated flaps for total face restoration.
3. Agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent.

Exclusion Criteria:

1. Patients with severe liver, kidney or lung insufficiency, and allergy to iodine products
2. Patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate.
3. Minor patients without legal guardian.
4. Not willing to participate; informed consent form not signed.

Primary outcomes:
measure: The arterial infusion rate of flap before flap fenestration
timeFrame: 10 minutes
measure: The arterial infusion rate of flap after flap fenestration
timeFrame: 10 minutes
Secondary outcomes:
measure: The occurrence rate of flap necrosis
timeFrame: 2 weeks post-operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
References: