A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin (NCT04544566) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
Denmark12 participantsStarted 2020-07-07
Plain-language summary
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have had a stoma for more than ½ year
* Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).
* Willing to change baseplate every second day or less frequent
* Willing to avoid using Concave baseplate during the study.
* Willing to avoid the use of barrier creams or similar that affect the skin/adhesive interface under the tape.
Exclusion Criteria:
* Currently receiving or have within the past 2 months received radio-and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet(injection) treatment
* Is pregnant or breastfeeding
* Having dermatological problems in the peristomal area (assessed by investigator)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Adherent Area Measured by Photo of Used Tape
Timeframe: Tapestrips per test product were removed from the baseplate at each product change and saved for the next site visit every 7-9 days for evaluation