An interventional study of 3D Printed Personalized Ostomy Appliance in 3D Printing, Ostomy and Leakage, sponsored by Carilion Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Carilion Clinic · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is:
Participants will
Formation of an ostomy is an operation that connects a hollow viscus, such as the bowel, to the skin. An ostomy appliance is worn to collect waste around the stoma, the externalized viscus organ. Ostomy appliances are emptied several times a day and are exchanged as infrequently as once per week or as frequently as multiple times per day. Unfortunately, half of all patients with an ostomy will suffer from complications such as peristomal skin breakdown, skin irritation, leaks, and bleeding. Stoma measuring guides are used to measure the ostomy appliance to achieve a well-fit skin barrier and prevent peristomal skin complications. Leaks both dramatically decrease patients' quality of life and result in skin irritation and other complications including infections.
Investigators propose utilizing advances in 3D scanning, computer-aided design (CAD) modeling, and 3D manufacturing to create a personalized ostomy appliance.
Site investigators will develop a 3D personalized ostomy appliance protocol featuring three phases: first, the patient's stoma is scanned using a 3D scanner in CRSudio2; second, the raw scan is edited using personalized variables to create a filtered mesh; third, the filtered mesh is printed to provide an ostomy template to the patient and currently available ostomy appliances are modified using a laser cutter to provide a personalized ostomy appliance to the patient. The selection of commercially available ostomy appliance will be done in coordination with the ostomy nursing team. Based upon the patient's body habitus and stoma, the ostomy nurse will select the recommended appliance that is available at Carilion Clinic. This will be the appliance that is customized using the laser cutter.
Exclusion Criteria:
The personalized ostomy appliances are designed based off of a 3D scan. We will scan your ostomy to create a 3D picture in the computer system that is an exact copy of your ostomy using plastic. We then apply computer aided design (CAD) tools to modify your normal ostomy baseplates.
Device: 3D Printed Personalized Ostomy Appliance
Study procedures will include getting your stoma scanned, receiving personalized ostomy appliances in the mail, receiving a personalized ostomy template, which will be printed using a 3D printer, in the mail, and completing a daily symptom diary along with a weekly survey for 4 weeks.3D printing is done using a machine that takes the 3D image from the computer and prints a replica of the image using plastic or other materials.
Incidence of Leaks
Number of leaks experienced on a daily basis by participant
Time frame: 28 days
Number of appliances
Number of ostomy bag changes completed by participant
Time frame: 28 days
Overall patient satisfaction
Ostomy Leak Appliance Tool Survey will ask participants to answer questions related to their experiences of leaking within the previous 7 days, including information on the frequency of leakage and emotional impact of how a leak or risk of leakage affected how the participant felt. Participants will answer how they felt, whether they were able to complete usual day to day activities and how they coped by answering on a scale of "All of the time," "Often," "Sometimes," or "Rarely or never."
Time frame: 28 days
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