Nyirjesy Sarah C, Judd Ryan T, Alfayez Yazen, Lancione Peter, Swendseid Brian, von Windheim Natalia, Nogan Stephen, Seim Nolan B, VanKoevering Kyle K
Department of Otolaryngology- Head and Neck Surgery, The James Cancer Hospital and Solove Research Institute, The Ohio State University Wexner Medical Center, 915 Olentangy River Road, Columbus, OH, 43210, USA.
3D Print Med. 2023 Feb 23;9(1):4. doi: 10.1186/s41205-022-00166-4.
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.
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.
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.
由于重要结构位置临近，复杂面部伤口难以实现稳定。我们报告了一例使用计算机辅助设计和即时三维打印制作患者特异性伤口夹板的病例，该病例用于在半侧面部坏死性筋膜炎情况下实现伤口稳定。我们还描述了美国食品药品监督管理局医疗器械扩大准入紧急使用机制的流程和实施情况。
一名58岁女性患者出现颈部和半侧面部坏死性筋膜炎。经过多次清创后，她病情仍然危急，伤口床组织血运差，没有健康肉芽组织形成，且担心伤口会进一步向右侧眼眶、纵隔和气管前软组织破溃，尽管已长时间插管但仍无法进行气管切开术。考虑使用负压伤口引流来促进愈合，但由于靠近眼睛，担心会因牵引损伤导致视力丧失。作为解决方案，根据食品药品监督管理局的医疗器械扩大准入紧急使用机制，我们通过CT扫描设计了一种三维打印的、患者特异性硅胶伤口夹板，使伤口引流装置固定在夹板上而非眼睑上。经过5天的夹板辅助负压治疗后，伤口床稳定，无残留脓性分泌物，长出了健康的肉芽组织，眼睛和下眼睑未受损伤。继续进行负压治疗后，伤口收缩，1个月后得以安全地进行气管切开术、撤机、经口进食，并采用胸大肌肌筋膜瓣和正中旁前额瓣进行半侧面部重建。她最终拔除气管套管，在6个月的随访中伤口愈合良好，眶周功能正常。
患者特异性三维打印是一种创新解决方案，可促进在脆弱结构附近安全放置负压伤口治疗装置。本报告还展示了即时制造定制设备以优化头颈部复杂伤口管理的可行性，并描述了成功使用美国食品药品监督管理局医疗器械扩大准入紧急使用机制的情况。
