Evaluation of ostomy skin conditions using digital images
A Single-Time-Point, Observational Study to Evaluate Interrater Reliability of SACS 2.0 for the Assessment of Peristomal Skin Health in Ostomates
This study is testing if using digital photos of ostomy skin conditions can help doctors understand and manage care for patients with ileostomy, colostomy, or urostomy better than traditional in-person check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ConvaTec Inc. Industry-sponsored |
| Locations | 3 sites (São Paulo and 2 other locations) |
| Trial ID | NCT06614491 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive dataset of ostomy conditions by collecting stoma photographs. It will evaluate the effectiveness of digital image assessments compared to traditional in-person evaluations of ostomy skin health. The study focuses on patients with ileostomy, colostomy, or urostomy, and will gather data to enhance understanding and management of ostomy care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have an ileostomy, colostomy, or urostomy.
Not a fit: Patients with enterocutaneous fistulae or those who have two or more ostomies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the assessment and management of ostomy skin conditions, leading to better patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel evaluation method.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
São Paulo and 2 other locations
- ConvaCare clinic — São Paulo, Brazil (Recruiting)
- ConvaCare clinic — Bogotá, Colombia (Recruiting)
- ConvaCare clinic — Medellín, Colombia (Recruiting)
Study contacts
- Principal investigator: Sandra Guerrero, MD — Principal Investigator Colombia
- Study coordinator: Jan Ljungqvist
- Email: jan.ljungqvist@convatec.com
- Phone: 0782557961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.