eP814 - 3D-Personalized Ostomy Appliance Impact on Quality of Life – A Prospective Clinical Trial on Efficacy

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Purpose/Background: Approximately half of all patients living with an ostomy will experience complications including leakage or peristomal skin breakdown. Patients may have trouble pouching commercially available ostomy appliances for several reasons including a challenging peristomal abdominal wall contour, existing peristomal wounds, and/or patient/caregiver dexterity limitations. Recent advances in 3D scanning, computer-aided design software, and 3D manufacturing technologies enable the personalization of ostomy appliances.Methods/Interventions: We seek to enroll 40 patients living with an ostomy for a one-month prospective clinical trial comparing 3D-personalized ostomy appliances versus standard of care. At intake, the patient will have their ostomy scanned using a high-resolution 3D scanner. The mesh model will then be filtered using CAD software for eventual 3D printing and customization of commercially available ostomy appliances. Patients will complete daily symptom journals and a weekly Ostomy Leak Impact Tool survey to compare 2-weeks of standard of care versus 2-weeks of the personalized ostomy appliance protocol.Results/Outcomes: We hypothesize that our 3D-personalized ostomy appliance will result in improved quality of life scores and decreased leaks when compared to standard of care. The primary outcome will be improved Ostomy Leak Impact Tool scores. Secondary outcomes will examine the number of leaks and appliance changes.Conclusion/

Discussion: We are initiating a prospective clinical trial leveraging 3D scanning, computer-aided design software and 3D manufacturing technology to create personalized ostomy appliances.Personalized Ostomy Appliance Processing3D scan of a representative patient’s end colostomy (top) with subsequent filtering to identify the mucocutaneous junction (bottom) for eventual 3D manufacturing of a personalized ostomy appliance.