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临床试验/NCT03345732
NCT03345732撤回不适用

Intraoperative Evaluation Using Indocyanine Green and SPY Fluorescence Angiography to Prevent Wound Complications in Head and Neck Surgery Patients, an Observational Study

University Health Network, Toronto1 个研究点 分布在 1 个国家开始时间: 2016年12月8日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
ICG/SPY system for tissue viability

研究概览

简要总结

Wound complications, such as salivary-cutaneous fistulas and skin necrosis, result in significant patient morbidity and death. Head and neck wounds are complicated because of multiple tissue layers, critical structures and variable vascularity. When vascularity is compromised, wounds do not heal and can lead to life threatening haemorrhage or morbid infections. The field of microsurgical reconstruction has developed and expanded over the last 20 years to specifically ameliorate these issues. The challenge is that the vascularity of the microsurgical transplant or the recipient tissue bed can have areas of decreased vascularity that cannot be appreciated by the surgeon's intraoperative exam alone. Surgeons would be able to make better decisions with respect to the vascularity if there was an imaging technique that could indicate the vascular supply of the tissues undergoing surgical reconstruction.

Laser-assisted indocyanine green fluorescent dye angiography (LA-ICG) using the SPY System (Novadaq Technologies Inc., Richmond, British Columbia, Canada) is an intraoperative vascular imaging technique that improves the ability of a surgeon to assess the vascular supply in the surgical bed. This tool, which is approved by Health Canada for reconstructive surgery, has been used extensively in breast reconstruction and gastrointestinal procedures with encouraging results. The ability to address ischemic tissues intraoperatively could potentially decrease the rate of devastating wound complications in head and neck surgery patients. The objective of this observational study is to assess the effectiveness of LA-ICG in head and neck reconstructive procedures to reduce the rate of skin necrosis and fistula.

详细描述

This is a prospective, observational study in patients undergoing head and neck surgery with reconstruction. Patients will be identified preoperatively by the participating surgeons. Eligible patients will be >18 years of age with head and neck oncologic or traumatic reconstructive needs requiring surgical reconstruction of the soft tissues or bony structures of the head and neck who consent to use of ICG and the SPY System intraoperatively. Defect types to be included in the study are any hypopharyngeal defect (i.e. Total laryngectomy, total laryngectomy with partial pharyngectomy), tracheal defects, oral cavity defects at risk for devascularized mucosa, or large skin defects requiring rotation-advancement flaps for closure. Donor types to be included are pedicled locoregional muscle flaps including pectoralis muscle flaps, cervicofacial skin advancement flaps, infrascapular and suprascapular flaps, and any free flap used to reconstruct the defects mentioned previously.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>18 years old) who are undergoing reconstruction for traumatic or oncologic head and neck wounds
  • Specific defects eligible are any pharyngeal, tracheal, or oral cavity defects at risk of devascularized mucosa, or large skin defects requiring skin advancement flaps. This includes laryngectomy/laryngectomy-partial pharyngectomy with primary closure.
  • Patient with the above defects that will be having reconstruction with the following donor tissues: local, regional or autogenous free flaps.
  • Informed consent

排除标准

  • Patients who are pregnant or nursing
  • Patients with an allergy to iodine (contrast ICG dye contains sodium iodide)

结局指标

主要结局

ICG/SPY system for tissue viability

时间窗: introperatively

To determine how often ICG/SPY system can be used to determine debridement of recipient or donor tissue during head and neck reconstruction

次要结局

  • Amount of tissue debridement(intraoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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