3D Printed Personalized Ostomy Appliance
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
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
Treatments tested in this trial
- 3D Printed Personalized Ostomy Appliance
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Carilion Clinic
Lead sponsor
Virginia Polytechnic Institute and State University
Collaborator
Source ClinicalTrials.gov