NCT06614491已完成不适用
A Single-Time-Point, Observational Study to Evaluate Interrater Reliability of SACS 2.0 for the Assessment of Peristomal Skin Health in Ostomates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 605
- 试验地点
- 4
- 主要终点
- Reliability of SACS assessment
研究概览
简要总结
Study to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ileostomy, colostomy or urostomy
- •Age ≥ 18 years of age
- •Able and willing to provide informed consent
排除标准
- •Enterocutaneous fistulae
- •Patients with two or more ostomies
研究组 & 干预措施
Ileostomy
Subjects with ileostomy
Colostomy
Subjects with colostomy
Urostomy
Subjects with urostomy
结局指标
主要结局
Reliability of SACS assessment
时间窗: 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
次要结局
- Ostomy dataset(Baseline)
研究者
研究点 (4)
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