3D Printed Personalized Ostomy Appliance

Launched by CARILION CLINIC · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well a personalized ostomy appliance made using a 3D scan can reduce leakages and improve the quality of life for people with an ostomy. An ostomy is a surgery that creates an opening in the body for waste to leave, and some people struggle with leakage from their appliances. The trial will involve participants using their usual ostomy appliance for two weeks and then switching to the new personalized one for another two weeks. During this time, they will answer daily questions and complete weekly surveys about how they feel and how well the appliances are working for them.

To participate, individuals should be between 18 and 100 years old, have had their current ostomy appliance for at least six weeks, and have experienced leakage in the week before joining the study. They also need to be able to use a phone and have internet access for surveys. This trial is currently looking for participants, so if you or someone you know meets these criteria and is interested, it could be a great opportunity to help improve ostomy care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-100 years old
• • Must have had current ostomy appliance for \> 6 weeks - if patients with stomas less than 6 weeks are included, their personalized templates will not be useful once the stoma size has changed after their initial scan.
• • Must have experienced \> 1 leakage in the week leading up to day of consent. - If patients are not experiencing leakages, then there will be no baseline data to compare effectiveness of the post-3D appliance intervention.
• • Participants must be able to consent for themselves
• • Access to phone AND computer with internet access. Patient must be able to provide electronic mailing address for e-consent documentation and REDCap surveys.
• Exclusion Criteria:
• • Concern for patient being able to be reached over the phone or reliable internet access for REDCap survey completion
• • Existing peri-stomal skin breakdown including ulceration or mucocutaneous separation.
• • Diagnosis of infection around the peristomal region. (erythema is NOT an exclusion criteria)