A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Mean Adherent Area Measured by Photo of Used Tape
Study Overview
Brief 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.
Detailed Description
The test products are 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Mean Adherent Area Measured by Photo of Used Tape
Time Frame: 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
The adherent area (cm2) measured per baseplate change after use shows how effectively the ostomy tape adheres to the skin. After removal of the ostomy tape, a photo of the tape was taken. The adherent area was measured from the photo and an image analysing program.
Secondary Outcomes
- Erythema Measured After Tape Removal by Photos(The measurements were carried out after 7-9 days of treatment with the test tape)
- Erythema Measured After Each Treatment Period by Spectrophotometric Method(The measurements were carried out after 7-9 days of treatment with the test tape)
- Feeling of Security(The evaluation was carried out after 7-9 days of treatment with the test tape)
- Comfort(The evaluation was carried out after 7-9 days of treatment with the test tape)
- Skin Issues in the Area Covered by the Tape(The evaluation was carried out after 7-9 days of treatment with the test tape)
- Adverse Events(27 days)
- Adhesion of Tape(The evaluation was carried out after 7-9 days of treatment with the test tape)