SCOPE - Single-Point Classification Observational Peristomal Evaluation

ConvaTec Inc.605 enrolled

Overview

Study to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment.

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 Type

OBSERVATIONAL

Enrollment

605

Conditions

Ileostomy Colostomy Urostomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

ConvaCare clinic

São Paulo, Brazil

ConvaCare clinic

Bogotá, Colombia

Convacare clinic

Cali, Colombia

ConvaCare clinic

Medellín, Colombia

Outcomes

Primary Outcomes

Reliability of SACS assessment

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

Time frame: Baseline

Secondary Outcomes

Ostomy dataset

Frequency of peristomal skin health classification scores in 600 consecutive ostomates

Time frame: Baseline

Data from ClinicalTrials.gov

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