Clinical trial NCT04544566: A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
Official title: A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Site Leakage
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Erythema Measured After Each Treatment Period by Spectrophotometric Method
timeFrame: The measurements were carried out after 7-9 days of treatment with the test tape
measure: Erythema Measured After Tape Removal by Photos
timeFrame: The measurements were carried out after 7-9 days of treatment with the test tape
measure: Feeling of Security
timeFrame: The evaluation was carried out after 7-9 days of treatment with the test tape
measure: Adhesion of Tape
timeFrame: The evaluation was carried out after 7-9 days of treatment with the test tape
measure: Comfort
timeFrame: The evaluation was carried out after 7-9 days of treatment with the test tape
measure: Skin Issues in the Area Covered by the Tape
timeFrame: The evaluation was carried out after 7-9 days of treatment with the test tape
measure: Adverse Events
timeFrame: 27 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg hospital, Dermato-Venerologisk afdeling.
name: Tonny Karlsmark, MD
role: PRINCIPAL_INVESTIGATOR
References: