NCT06614491CompletedNot Applicable
A Single-Time-Point, Observational Study to Evaluate Interrater Reliability of SACS 2.0 for the Assessment of Peristomal Skin Health in Ostomates
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ConvaTec Inc.
- Enrollment
- 605
- Locations
- 4
- Primary Endpoint
- Reliability of SACS assessment
Study Overview
Brief Summary
Study to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment.
Detailed Description
The purpose of this study is to create an ostomy dataset and collect stoma photos to enable SACS 2.0 evaluation of images digitally versus an in-person ostomy skin assessment.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with ileostomy, colostomy or urostomy
- •Age ≥ 18 years of age
- •Able and willing to provide informed consent
Exclusion Criteria
- •Enterocutaneous fistulae
- •Patients with two or more ostomies
Arms & Interventions
Ileostomy
Subjects with ileostomy
Colostomy
Subjects with colostomy
Urostomy
Subjects with urostomy
Outcomes
Primary Outcomes
Reliability of SACS assessment
Time Frame: Baseline
The equivalence of weighted Kappa concordance between SACS assessment via in-person skin assessment by an ostomy care nurse and SACS assessment via examining the skin via photo by a study nurse coordinator
Secondary Outcomes
- Ostomy dataset(Baseline)
Investigators
Study Sites (4)
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