3D Printed Personalized Ostomy Appliance

Phase

N/A

Condition

N/A

Treatment

3D Printed Personalized Ostomy Appliance

Clinical Study ID

NCT06310070

IRB-23-1965

Ages 18-100
All Genders
Accepts Healthy Volunteers

Study Summary

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:

• Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance.

Participants will

Spend 2 weeks with their standard of care ostomy appliance
Spend 2 weeks with their personalized ostomy appliance made from a 3D scan
Participate in daily surveys and weekly quality of life surveys conducted over the phone

Eligibility Criteria

Inclusion

Inclusion Criteria:

18-100 years old
Must have had current ostomy appliance for > 6 weeks - if patients with stomas lessthan 6 weeks are included, their personalized templates will not be useful once thestoma size has changed after their initial scan.
Must have experienced > 1 leakage in the week leading up to day of consent. - Ifpatients are not experiencing leakages, then there will be no baseline data tocompare 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 provideelectronic mailing address for e-consent documentation and REDCap surveys.

Exclusion

Exclusion Criteria:

Concern for patient being able to be reached over the phone or reliable internetaccess for REDCap survey completion
Existing peri-stomal skin breakdown including ulceration or mucocutaneousseparation.
Diagnosis of infection around the peristomal region. (erythema is NOT an exclusioncriteria)

Study Design

3D Printed Personalized Ostomy Appliance

May 10, 2024

June 05, 2025

Study Description

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.

Connect with a study center

Carilion Clinic
Roanoke, Virginia 24013
United States
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.