RESUMEN
Additive manufacturing techniques allow the customized design of medical devices according to the patient's requirements. Enteroatmospheric fistula is a pathology that benefits from this personalization due to its extensive clinical variability since the size and morphology of the wound differ extensively among patients. Standard prosthetics do not achieve proper isolation of the wound, leading to a higher risk of infections. Currently, no effective personalized technique to isolate it has been described. In this work, we present the workflow for the design and manufacture of customized devices adapted to the fistula characteristics as it evolves and changes during the treatment with Negative Pressure Wound Therapy (NPWT). For each case, a device was designed with dimensions and morphology depending on each patient's requirements using white light scanning, CAD design, and additive manufacturing. The design and manufacture of the devices were performed in 230.50 min (184.00-304.75). After the placement of the device, the wound was successfully isolated from the intestinal content for 48-72 h. The therapy was applied for 27.71 ± 13.74 days, and the device was redesigned to adapt to the wound when geometrical evolutionary changes occur during the therapy. It was observed a decrease in weekly cures from 23.63 ± 10.54 to 2.69 ± 0.65 (p = 0.001). The fistulose size was reduced longitudinal and transversally by 3.25 ± 2.56 cm and 6.06 ± 3.14 cm, respectively. The wound depth also decreased by 1.94 ± 1.08 cm. In conclusion, customization through additive manufacturing is feasible and offers promising results in the generation of personalized devices for the treatment of enteroatmospheric fistula.
RESUMEN
Enteroatmospheric fistulae are challenging clinical conditions that require surgical expertise and that can result in chronic debilitating conditions placing the patient in a vicious cycle characterized by non healing wounds and malnutrition. They are a complex entity that presents great variability depending on the number, shape, and size of the fistulous orifices, their debit, and the dimensions of the wound. This means that, at present, there is no device that adapts to the anatomical characteristics of each patient and manages to control the spillage of intestinal effluvium from the wound. The aim of this study is to describe the manufacturing technique and to assess the preliminary results of a custom device designed through bioscanner imaging and manufactured using 3D printing for use with negative pressure wound therapy (NPWT) in the management of enteroatmospheric fistula. A proof of concept is given, and the design of the device is presented for the first time. After obtaining images of each fistula with a bioscanner, a personalised device was designed for each patient by 3D printing shape of a prism and a hollow base, taking into account the dimensions of the fistulous area in order to perform a floating ostomy to isolate the wound from the debit enteric. The polycaprolactone (PCL) device was placed including inside the fistulous surface and surrounding it with the NPWT system in order to accelerate wound healing.
