Health TrialsbyHealthPanel

3D Printed Personalized Ostomy Appliance

Conditions3D PrintingOstomyLeakage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCarilion Clinic

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 3D Printed Personalized Ostomy Appliance

    Device

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Receiving 3D Personalized Ostomy ApplianceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Leaks

Number of leaks experienced on a daily basis by participant

Time frame
28 days

Secondary outcomes

1

Number of appliances

Number of ostomy bag changes completed by participant

Time frame
28 days
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carilion Clinic

Lead sponsor

Virginia Polytechnic Institute and State University

Collaborator

Source ClinicalTrials.gov
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