ATTRACT-I: A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3)
研究概览
简要总结
This investigation is a randomized, controlled, open-label, comparative, cross-over, multicenter investigation, with two test periods. In total, 82 subjects will be included and randomized, and each subject will have three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days in total for the entire investigation, thus approximately 70 days. The subjects will test the non-CE marked test product and the comparator product in randomized order.
详细描述
People with intestinal stomas have, despite development of better stoma products, problems with leakage induced peristomal skin complications which influence quality of life negatively. In fact, the primary cause of peristomal skin complication development is due to leakage of ostomy effluents under the adhesive barrier. Some of the common clinical signs of peristomal skin complications include pain, itching, burning, discoloration, bleeding, and wounds . To overcome this, Coloplast A/S has developed a new baseplate which is comprised of a protective layer.
This investigation is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation, with two test periods. In total 82 subjects will be included and randomised, and each subject will have at least three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days; thus approximately 70 days. The subjects will test the non-CE marked investigational product and the comparator product in a randomised order.
Before the test periods, the subjects are invited for a screening visit (V0). Subjects will be consented prior to any study procedures. Once consented, during their participation, the subjects will complete three study visits (V1, V2 and V3). The visits can be at the Principal Investigators clinic or in the subject's home. In rare cases (i.e. global pandemic), visits can be done remotely via video conference. In addition, the Principal Investigator, or designee, will call the subjects four times during the course of the investigation to inquire if the subject has had any issues or concerns.
During the test visits the subject will complete a quality of life questionnaire and discuss/record any adverse events or device deficiencies. The subject will also be asked about the use and handling of the product, and their preference.
At every baseplate change the subjects will be asked to take photos of their stoma/peristomal skin and the backside (adhesive side) of the used product. The photos will be taken with a smartphone using the Coloplast Clinical Trial App. The subject will also be asked to complete a questionnaire about their peristomal skin condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •Has given written consent to participate by signing the Informed Consent Signature Form
- •Is at least 18 years of age and have full legal capacity
- •Has an ileostomy or colostomy with consistent liquid fecal output (6-7 Bristol scale.
- •Is currently using a SenSura® Mio flat product with open bag.
- •Has had the ostomy for at least 90 days.
- •Can use an ostomy product with a max cut size of 45 mm (1-piece) or 38 mm (2-piece).
- •Has experienced leakage** under the baseplate at least three times within the last fourteen days.
- •**Leakage defined as output/seeping under the baseplate (see appendix 7)
- •Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last fourteen days. **
- •** Proper training of the PI and nurses in how to ask the subject about these symptoms is essential.
- •Is able to handle the electronic diary (questionnaire/photo) themselves. If needed, a trained spouse or caretaker is allowed to assist.
- •Is able to handle (apply, remove, cut, etc.) the product themselves.
- •Understands that any barrier products (film, cream, spray, wipes etc.) are not permissible during the investigation, and is willing to not use these accessories during the investigation.
- •Is willing and suitable (determined by the Principal Investigator or designee) to use a flat custom cut one-piece open or two-piece open product during the investigation.
- •Is willing to change the product (1-piece) or baseplate (2-piece) at least every fourth days.
排除标准
- •Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.
- •low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
- •Is currently receiving or have within the past 30 days 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 investigator are allowed.
- •Other systemic steroid treatment (e.g., injection or tablet) are not allowed.
- •Is breastfeeding.
- •Is pregnant based on urine pregnancy test.
- •Has known hypersensitivity towards any of the products used in the investigation.
结局指标
主要结局
The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3)
时间窗: after 5 weeks
The peristomal skin condition measured by the Decision Tree Score on baseplate level at steady state (scale from 0-3). Higher score means worse outcome
次要结局
- Health-related Quality of Life (Scale 0-30)(5 weeks)