N/A
N=12
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
Stoma Site Leakage
Bottom Line
View on ClinicalTrials.gov: NCT04544566 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Mean Adherent Area Measured by Photo of Used Tape — 46.54; 51.61; 52.94 Cm2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test product A (Device); Test product B (Device); Comparator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Adherent Area Measured by Photo of Used Tape |
46.54; 51.61; 52.94 | — |
| SECONDARY Erythema Measured After Each Treatment Period by Spectrophotometric Method |
10.1; 10.0; 11.0 | — |
| SECONDARY Erythema Measured After Tape Removal by Photos |
6; 6; 3; 1; 4; 2 | — |
| SECONDARY Feeling of Security |
3; 0; 0; 9; 0; 0 | — |
| SECONDARY Adhesion of Tape |
5; 0; 0; 11; 0; 0 | — |
| SECONDARY Comfort |
2; 3; 0; 5; 5; 2 | — |
| SECONDARY Skin Issues in the Area Covered by the Tape |
18; 13; 6; 34; 36; 41 | — |
| SECONDARY Adverse Events |
1; 1; 1 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04544566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.