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.

BACKGROUND: Previous studies have demonstrated that, by using various three-dimensional (3D) printing technologies, synthetic spine models can be manufactured to mimic a human spine in its gross and radiographic anatomy and the biomechanical performance of bony and ligamentous tissue. These manufacturing processes have not, however, been used in combination to create a long-segment, biomimetic model of a patient with scoliosis. The purpose of this study was to describe the development of a biomimetic scoliosis model and early clinical experience using this model as a surgical planning and education platform.
METHODS: Synthetic spine models were printed to mimic the anatomy and biomechanical performance of 2 adult patients with scoliosis. Preoperatively, the models were surgically corrected by the attending surgeon of each patient. Patients then underwent surgical correction of their spinal deformities. Correction of the models was compared to the surgical correction in the patients.
RESULTS: Patient 1 had a preoperative coronal Cobb angle of 40° from L1 to S1, as did the patient\'s synthetic spine model. The patient\'s spine model was corrected to 17.6°, and the patient achieved a correction of 17.3°. Patient 2 had a preoperative mid-thoracic Cobb angle of 88° and an upper thoracic Cobb angle of 43°. Preoperatively, the patient\'s spine model was corrected to 19.5° and 9.2° for the mid-thoracic and upper thoracic curves, respectively. Immediately after surgery, the patient\'s mid-thoracic and upper thoracic Cobb angles measured 18.7° and 9.5°, respectively. In both cases, the use of the spine models preoperatively changed the attending surgeon\'s operative plan.
CONCLUSIONS: A novel synthetic spine model for corrective scoliosis procedures is presented, along with early clinical experience using this model as a surgical planning platform. This model has tremendous potential not only as a surgical planning platform but also as an adjunct to patient consent, surgical education, and biomechanical research.