A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

Conditions
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Stoma Site Leakage

Intervention / Treatment
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* Device: Test product A
* Device: Test product B
* Device: Comparator


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product A new adhesive material<br>The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin. | Device: Test product A<br>* one new adhesive material which is applied to the baseplate and the subjects peristomal skin<br>Device: Test product B<br>* one new adhesive material which is applied to the baseplate and the subjects peristomal skin<br>Device: Comparator<br>* Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin<br>|
| Experimental: Test product B new adhesion material<br>The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin. | Device: Test product A<br>* one new adhesive material which is applied to the baseplate and the subjects peristomal skin<br>Device: Test product B<br>* one new adhesive material which is applied to the baseplate and the subjects peristomal skin<br>Device: Comparator<br>* Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin<br>|
| Active Comparator: Comparator<br>The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation. | Device: Test product A<br>* one new adhesive material which is applied to the baseplate and the subjects peristomal skin<br>Device: Test product B<br>* one new adhesive material which is applied to the baseplate and the subjects peristomal skin<br>Device: Comparator<br>* Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Adherent Area Measured by Photo of Used Tape | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema Measured After Each Treatment Period by Spectrophotometric Method | A change in the surface skin colour is known to be related to a change in the blood flow. This can be measured non-invasively with a spectrophotometric instrument (Derma-spectrophotometer, Cortex Technology A/S, Hadsund) where redness of the skin is measured. The measurement of erythema is based on an active color detecting chip. Illumination is provided by two high intensity white LEDs. The spectrophotometer accommodates the color sensor, filters, optics and light source. Light is provided by two high intensity with LEDs and a unique feature is the guiding light, which illuminates the target during the positioning of the device. The LEDs illuminates the target area and the skin color measurement is performed. The measurements performed with the spectrophotometric instrument do not have units. But the measures are used for the estimation of the level of the redness (hemoglobin) in the skin. The higher the value, the more pigment in the skin. | The measurements were carried out after 7-9 days of treatment with the test tape | 
| Erythema Measured After Tape Removal by Photos | A change in the surface skin colour is known to be related to a change in the blood flow. This can be measured non-invasively with a spectrophotometric instrument (Derma-spectrophotometer, Cortex Technology A/S, Hadsund) where both the redness and the colour of the skin are measured. Furthermore, visual assessments of photos have been used in several exploratory clinical investigations by Coloplast A/S to explore how adhesives affect the skin. The visual assessment is conducted by trained personnel and is a valuable tool for assessing newly developed adhesives and their impact on skin in the early development phases. | The measurements were carried out after 7-9 days of treatment with the test tape | 
| Feeling of Security | Subjects will be asked how they rate feeling of security (How was the feeling of security?) on a five point scale, when wearing the tape; 1. Very Poor, 2. Poor, 3. Acceptable, 4. Good, 5. Very Good. | The evaluation was carried out after 7-9 days of treatment with the test tape | 
| Adhesion of Tape | Subjects will be asked how they perceive the immediate adhesion to the skin (how was the immediate adhesion to the skin?) and rate adhesion on a five-point scale: 1. Very poor, 2. Poor, 3. Acceptable, 4. Good, 5. Very good. | The evaluation was carried out after 7-9 days of treatment with the test tape | 
| Comfort | Subjects will be asked how they perceived the comfort of the tape (How comfortable was the tape to wear?) and rate comfort on a 5-pont scale; 1. very discomfortable, 2. Discomfortable, 3. Acceptable, 4. Comfortable, 5. Very comfortable. | The evaluation was carried out after 7-9 days of treatment with the test tape | 
| Skin Issues in the Area Covered by the Tape | Subjects will be asked if they had any skin-related complications in the area covered by the tape (yes, no). | The evaluation was carried out after 7-9 days of treatment with the test tape | 
| Adverse Events | All Adverse Events are captured and documented throughout the study. | 27 days |