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临床试验/NCT05360355
NCT05360355已完成不适用

Flap Fenestration and Facial Organ Fabrication Guided By Intraoperative Indocyanine Green Angiography in Total Facial Restoration

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
The arterial infusion rate of flap before flap fenestration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

The arterial infusion rate of flap before flap fenestration

时间窗: 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

时间窗: 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.

次要结局

  • The occurrence rate of flap necrosis(2 weeks post-operation)

研究者

发起方
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tao Zan, MD, Ph.D

Clinical professor

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

研究点 (1)

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