Flap Fenestration and Facial Organ Fabrication Guided by ICGA

NCT ID: NCT05360355

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-06-01

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.

Conditions

Surgery

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

total face reconstruction surgery and intraoperative indocyanine green angiography

Intervention Type: 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.

Interventions

total face reconstruction surgery and intraoperative indocyanine green angiography

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Tao Zan, MD, Ph.D

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37382913 (View on PubMed)

Other Identifiers

ICGA Guided Flap Fenestration

Identifier Type: -

Identifier Source: org_study_id