What is this study trying to find out about ostomy care?

This study is evaluating whether using a 3D scan to create personalized ostomy appliances can reduce leaks and improve quality of life for people with an ostomy. Researchers want to see if this new approach fits better and causes fewer complications compared to standard appliances. The study is sponsored by Carilion Clinic and involves new 3D printing technologies.

Who may be eligible for this ostomy clinical trial?

Adults aged 18 to 100 who have used their current ostomy appliance for more than 6 weeks and experienced at least one leakage recently may be eligible. Participants must also have access to a phone and computer with internet, and be able to consent for themselves. Please review eligibility criteria for more details.

Is there any cost to participate in this ostomy clinical trial?

Study-related care, including the personalized ostomy appliance and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 100Years

All Genders

Healthy Volunteers

ID06310070

3D Printed Personalized Ostomy Appliance to Reduce Leakages and Improve Quality of Life

Led by Carilion Clinic · Updated on 2025-01-22

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of using a 3D scan to create personalized ostomy appliances for people with an ostomy. The study focuses on whether a 3D scan of the stoma can reduce leakages and improve quality of life compared to standard care. Ostomy appliances collect waste from the stoma but often cause complications such as skin irritation, leaks, and infections, which impact patients daily lives. Participants will have their stoma scanned with a 3D scanner to create a detailed digital model. This model is then edited and used to produce a personalized ostomy appliance by modifying standard appliances with a laser cutter. The study involves two 2-week periods where participants use their usual ostomy appliance first, then the personalized 3D-printed appliance. The personalized appliances are designed with input from an ostomy nursing team to ensure proper fit based on each patients body and stoma. During the 4-week study, participants will complete daily symptom diaries and weekly quality of life surveys conducted over the phone. Researchers will track leak incidents, the number of appliances used, and overall patient satisfaction. The study includes ongoing monitoring through electronic surveys requiring internet and device access. Total participation lasts about one month, with safety and quality of life as key measures.

CONDITIONS

Brief Title

3D Printed Personalized Ostomy Appliance

Who Can Participate

Age: 18Years - 100Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 100 years
Must have used current ostomy appliance for more than 6 weeks
Must have had more than one leakage in the week before consent
Able to consent for themselves
Access to a phone and a computer with internet to complete surveys and e-consent

You will not qualify if you...

Unreliable phone or internet access for survey completion
Existing peri-stomal skin breakdown including ulceration or mucocutaneous separation
Infection diagnosis around the peristomal region (except erythema)

Research Team

Adam Goode, MD

Uma Kelavkar

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