Clinical trial NCT06310070: 3D Printed Personalized Ostomy Appliance
Official title: 3D Printed Personalized Ostomy Appliance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 3D Printing
Ostomy
Leakage
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2024-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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

Detailed 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.

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)

Primary outcomes:
measure: Incidence of Leaks
timeFrame: 28 days
Secondary outcomes:
measure: Number of appliances
timeFrame: 28 days
measure: Overall patient satisfaction
timeFrame: 28 days
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Farrell Adkins, MD
role: PRINCIPAL_INVESTIGATOR
References: