Abstract：
BACKGROUND: Complex facial wounds can be difficult to stabilize due to proximity of vital structures. We present a case in which a patient-specific wound splint was manufactured using computer assisted design and three-dimensional printing at the point-of-care to allow for wound stabilization in the setting of hemifacial necrotizing fasciitis. We also describe the process and implementation of the United States Food and Drug Administration Expanded Access for Medical Devices Emergency Use mechanism.
METHODS: A 58-year-old female presented with necrotizing fasciitis of the neck and hemiface. After multiple debridements, she remained critically ill with poor vascularity of tissue in the wound bed and no evidence of healthy granulation tissue and concern for additional breakdown towards the right orbit, mediastinum, and pretracheal soft tissues, precluding tracheostomy placement despite prolonged intubation. A negative pressure wound vacuum was considered for improved healing, but proximity to the eye raised concern for vision loss due to traction injury. As a solution, under the Food and Drug Administration\'s Expanded Access for Medical Devices Emergency Use mechanism, we designed a three-dimensional printed, patient-specific silicone wound splint from a CT scan, allowing the wound vacuum to be secured to the splint rather than the eyelid. After 5 days of splint-assisted vacuum therapy, the wound bed stabilized with no residual purulence and developed healthy granulation tissue, without injury to the eye or lower lid. With continued vacuum therapy, the wound contracted to allow for safe tracheostomy placement, ventilator liberation, oral intake, and hemifacial reconstruction with a myofascial pectoralis muscle flap and a paramedian forehead flap 1 month later. She was eventually decannulated and at six-month follow-up has excellent wound healing and periorbital function.
CONCLUSIONS: Patient-specific, three-dimensional printing is an innovative solution that can facilitate safe placement of negative pressure wound therapy adjacent to delicate structures. This report also demonstrates feasibility of point-of-care manufacturing of customized devices for optimizing complex wound management in the head and neck, and describes successful use of the United States Food and Drug Administration\'s Expanded Access for Medical Devices Emergency Use mechanism.
METHODS: A 58-year-old female presented with necrotizing fasciitis of the neck and hemiface. After multiple debridements, she remained critically ill with poor vascularity of tissue in the wound bed and no evidence of healthy granulation tissue and concern for additional breakdown towards the right orbit, mediastinum, and pretracheal soft tissues, precluding tracheostomy placement despite prolonged intubation. A negative pressure wound vacuum was considered for improved healing, but proximity to the eye raised concern for vision loss due to traction injury. As a solution, under the Food and Drug Administration\'s Expanded Access for Medical Devices Emergency Use mechanism, we designed a three-dimensional printed, patient-specific silicone wound splint from a CT scan, allowing the wound vacuum to be secured to the splint rather than the eyelid. After 5 days of splint-assisted vacuum therapy, the wound bed stabilized with no residual purulence and developed healthy granulation tissue, without injury to the eye or lower lid. With continued vacuum therapy, the wound contracted to allow for safe tracheostomy placement, ventilator liberation, oral intake, and hemifacial reconstruction with a myofascial pectoralis muscle flap and a paramedian forehead flap 1 month later. She was eventually decannulated and at six-month follow-up has excellent wound healing and periorbital function.
CONCLUSIONS: Patient-specific, three-dimensional printing is an innovative solution that can facilitate safe placement of negative pressure wound therapy adjacent to delicate structures. This report also demonstrates feasibility of point-of-care manufacturing of customized devices for optimizing complex wound management in the head and neck, and describes successful use of the United States Food and Drug Administration\'s Expanded Access for Medical Devices Emergency Use mechanism.
摘要：
背景：由于重要结构的接近，复杂的面部伤口可能难以稳定。我们介绍了一个案例，在该案例中，使用计算机辅助设计和在护理点进行三维打印来制造患者特定的伤口夹板，以在半面部坏死性筋膜炎的情况下实现伤口稳定。我们还描述了美国食品和药物管理局扩大医疗设备紧急使用机制的过程和实施。
方法：一名58岁女性，表现为颈部和半面坏死性筋膜炎。经过多次清创,她仍然病危，伤口床中的组织血管不良，没有健康的肉芽组织的证据，并且担心向正确的轨道进一步破裂，纵隔,和气管前软组织，尽管插管时间延长，但仍无法进行气管造口术。负压伤口真空被认为是为了改善愈合，但是靠近眼睛引起了人们对牵引损伤导致视力丧失的担忧。作为解决方案,根据美国食品和药物管理局的扩大医疗设备紧急使用机制，我们设计了一个三维打印，CT扫描的患者专用硅胶伤口夹板，允许伤口真空固定在夹板上而不是眼睑上。夹板辅助真空治疗5天后，伤口床稳定，没有残留的脓液，并形成健康的肉芽组织，对眼睛或下眼睑没有伤害。通过持续的真空治疗，伤口收缩以允许安全的气管造口术放置，呼吸机解放,口服摄入，1个月后用胸肌肌肌皮瓣和前额旁正中皮瓣进行半面重建。她最终被拔管，在六个月的随访中具有出色的伤口愈合和眶周功能。
结论：患者特异性，三维打印是一种创新的解决方案，可以促进负压伤口治疗靠近精细结构的安全放置。本报告还展示了定制设备的现场护理制造的可行性，以优化头部和颈部的复杂伤口管理，并描述了美国食品和药物管理局扩大医疗设备紧急使用机制的成功使用。
方法：一名58岁女性，表现为颈部和半面坏死性筋膜炎。
结论：患者特异性，
