Flap Fenestration and Facial Organ Fabrication Guided by ICGA

NCT05360355 | Completed

• 1 other identifier: ICGA Guided Flap Fenestration
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Total facial restoration, Indocyanine green angiography, Flap fenestration, Facial organ fabrication, Flap surgery, Case series

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 minutes

Secondary Outcomes (1)

• The occurrence rate of flap necrosis

  2 weeks post-operation

Study Arms (1)

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.

Procedure: total face reconstruction surgery and intraoperative indocyanine green angiography

Interventions

total face reconstruction surgery and intraoperative indocyanine green angiography PROCEDURE

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.

patients undergone total face reconstruction and intraoperative indocyanine green angiography

Eligibility Criteria

• Age: 4 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

• 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.

  PMID: 37382913 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 4, 2022
• Study Start: June 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)