A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 24
- 主要终点
- Stoma Related Cost of Care
研究概览
简要总结
Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Ostomy patients who:
- •Have healthy peristomal skin
- •Are within 12 weeks post op
排除标准
- •Ostomy patients who:
- •Have a fistula, wound, lesion or suspected infection in the peristomal area
- •Are in-patient in healthcare facility
研究组 & 干预措施
Test Ostomy Barrier
The test product is a new Hollister ostomy barrier.
干预措施: Test Ostomy Barrier (Device)
Control Ostomy Barrier
The control product is a currently marketed Hollister ostomy barrier.
干预措施: Control Ostomy Barrier (Device)
结局指标
主要结局
Stoma Related Cost of Care
时间窗: 12 weeks
12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.
次要结局
- Peristomal Skin Complication Rate(8 weeks)