NL-OMON49482撤回不适用
Investigation of a new stoma product for people with a stoma - CP288
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Has given written consent to participate by signing the Informed Consent
- •Signature Form
- •2. Has an ileostomy or colostomy with liquid output (Definition of liquid
- •output: Six-Seven in the Bristol scale (Appendix 5 - Bristol scale)
- •3. Currently using a flat product
- •4. Be at least 18 years of age and have full legal capacity
- •5. Have had their stoma for at least three months (90 days)
- •6. Can use a product with a max cut size of 40 mm
- •7. Has experienced leakage* under the baseplate at least three times within the
- •last fourteen days. )*Leakage defined as output seeping under the baseplate
- •(Appendix 6 * Classification of leakage)
- •8. Has symptoms of peristomal skin complications or has peristomal skin
- •complications defined by at least one of the below
- •a) Has experienced symptoms of skin complications (itching, burning, pain)
- •within the last fourteen days
- •b) Has experienced red skin in the inner circle (within three cm from stoma
- •edge) within the last fourteen days
- •c) Has skin complication (assessed by Principal Investigator, or delegate) in
- •the inner circle (within three cm from stoma edge) of the peristomal area
- •9. Is able to handle the electronic diary (questionnaire/photo) themselves
- •10. Is able to handle (apply, remove, cut etc.) the product themselves
- •11. Is willing to not use barrier film or barrier cream during the
- •investigation
- •12. Is willing and suitable (determined by Principal Investigator, or delegate)
- •to use a flat custom cut one-piece open or a two-piece open product during the
- •investigation.
- •13. Is willing to change the product (1pc) or baseplate (2pc) at least every
- •fourth days.
排除标准
- •1. Is currently receiving or have within the past 60 days received radio-and/or
- •chemotherapy; low doses chemotherapy (assessed by Principal Investigator) is
- •allowed for indications other than cancer
- •2. Is currently receiving or have within the past month received topical
- •steroid treatment in the peristomal skin area, e.g. lotion or spray. Low dose
- •systemic steroid treatment (e.g. inhalation) assessed by the Principal
- •Investigator are allowed. Other systemic steroid treatment (e.g. injection, or
- •tablet) are not allowed.
- •3. Is breastfeeding
- •4. Is pregnant (based on pregnancy test - urine)
- •5. Has known hypersensitivity towards any of the products used in the
- •investigation
研究者
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