NCT06614491
Completed
Not Applicable
A Single-Time-Point, Observational Study to Evaluate Interrater Reliability of SACS 2.0 for the Assessment of Peristomal Skin Health in Ostomates
Overview
- Phase
- Not Applicable
- Intervention
- Ileostomy
- Conditions
- Ileostomy
- Sponsor
- ConvaTec Inc.
- Enrollment
- 605
- Locations
- 4
- Primary Endpoint
- Reliability of SACS assessment
- Status
- Completed
- Last Updated
- 3 months ago
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.
Investigators
Eligibility Criteria
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)
Study Sites (4)
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