Trial Outcomes & Findings for A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin (NCT NCT04544566)
NCT ID: NCT04544566
Last Updated: 2021-05-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome 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
Results posted on
2021-05-06
Participant Flow
All subjects that met the inclusion and exclusion criteria was randomised to one of six treatment arms. Each arm examined the Comparator Tape and the two Test Tapes in various orders.
Participant milestones
| Measure |
Test Tape A, Test Tape B, and Then Comparator Tape
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Test Tape A, Comparator Tape and Then Test Tape B
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Comparator Tape, Test Tape A and Then Test Tape B
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Comparator Tape, Test Tape B and Then Test Tape A
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Test Tape B, Comparator Tape and Then Test Tape A
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Test Tape B, Test Tape A and Then Comparator Tape
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Test Tape A, Test Tape B, and Then Comparator Tape
n=2 Participants
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Test Tape A, Comparator Tape and Then Test Tape B
n=2 Participants
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Comparator Tape, Test Tape A and Then Test Tape B
n=2 Participants
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Comparator Tape, Test Tape B and Then Test Tape A
n=2 Participants
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Test Tape B, Comparator Tape and Then Test Tape A
n=2 Participants
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Test Tape B, Test Tape A and Then Comparator Tape
n=2 Participants
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.
Test product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.
The comparator product is Brava Elastic tape which is a CE marked product already on the market and applied to the baseplate and the subjects peristomal skin. The product was used within the in-tended use in this clinical investigation.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
8 Participants
n=12 Participants
|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 26.2 • n=2 Participants
|
71 years
STANDARD_DEVIATION 0 • n=2 Participants
|
71.5 years
STANDARD_DEVIATION 6.4 • n=2 Participants
|
42.5 years
STANDARD_DEVIATION 30.4 • n=2 Participants
|
63 years
STANDARD_DEVIATION 19.8 • n=2 Participants
|
66 years
STANDARD_DEVIATION 0 • n=2 Participants
|
61.1 years
STANDARD_DEVIATION 17.4 • n=12 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
12 Participants
n=12 Participants
|
PRIMARY outcome
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 evaluationThe 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.
Outcome measures
| Measure |
Test Product A New Adhesive Material
n=12 Participants
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Test Product B New Adhesion Material
n=12 Participants
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Comparator
n=12 Participants
The comparator product is Brava Elastic tape which is already on the market and will be used within the intended use in this clinical investigation.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
|---|---|---|---|
|
Mean Adherent Area Measured by Photo of Used Tape
|
46.54 Cm2
Standard Deviation 1.23
|
51.61 Cm2
Standard Deviation 1.24
|
52.94 Cm2
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: The measurements were carried out after 7-9 days of treatment with the test tapeA 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.
Outcome measures
| Measure |
Test Product A New Adhesive Material
n=12 Participants
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Test Product B New Adhesion Material
n=12 Participants
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Comparator
n=12 Participants
The comparator product is Brava Elastic tape which is already on the market and will be used within the intended use in this clinical investigation.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
|---|---|---|---|
|
Erythema Measured After Each Treatment Period by Spectrophotometric Method
|
10.1 Unitless
Standard Deviation 2.6
|
10.0 Unitless
Standard Deviation 3.0
|
11.0 Unitless
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: The measurements were carried out after 7-9 days of treatment with the test tapePopulation: One subject from treatment-arm 6 is missing from the analysis as the photo material of the subject was insufficient for assessment.
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.
Outcome measures
| Measure |
Test Product A New Adhesive Material
n=11 Participants
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Test Product B New Adhesion Material
n=11 Participants
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Comparator
n=11 Participants
The comparator product is Brava Elastic tape which is already on the market and will be used within the intended use in this clinical investigation.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
|---|---|---|---|
|
Erythema Measured After Tape Removal by Photos
Lowest degree of skin reaction
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Erythema Measured After Tape Removal by Photos
Middle degree of skin reaction
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Erythema Measured After Tape Removal by Photos
Highest degree of skin reaction
|
4 Participants
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: The evaluation was carried out after 7-9 days of treatment with the test tapeSubjects 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.
Outcome measures
| Measure |
Test Product A New Adhesive Material
n=52 Product change
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Test Product B New Adhesion Material
n=49 Product change
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Comparator
n=47 Product change
The comparator product is Brava Elastic tape which is already on the market and will be used within the intended use in this clinical investigation.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
|---|---|---|---|
|
Feeling of Security
Very poor
|
3 Product change
|
0 Product change
|
0 Product change
|
|
Feeling of Security
Poor
|
9 Product change
|
0 Product change
|
0 Product change
|
|
Feeling of Security
Acceptable
|
14 Product change
|
2 Product change
|
4 Product change
|
|
Feeling of Security
Good
|
15 Product change
|
25 Product change
|
14 Product change
|
|
Feeling of Security
Very good
|
11 Product change
|
22 Product change
|
29 Product change
|
SECONDARY outcome
Timeframe: The evaluation was carried out after 7-9 days of treatment with the test tapeSubjects 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.
Outcome measures
| Measure |
Test Product A New Adhesive Material
n=52 Product change
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Test Product B New Adhesion Material
n=49 Product change
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Comparator
n=47 Product change
The comparator product is Brava Elastic tape which is already on the market and will be used within the intended use in this clinical investigation.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
|---|---|---|---|
|
Adhesion of Tape
Very poor
|
5 Product change
|
0 Product change
|
0 Product change
|
|
Adhesion of Tape
Poor
|
11 Product change
|
0 Product change
|
0 Product change
|
|
Adhesion of Tape
Acceptable
|
16 Product change
|
6 Product change
|
1 Product change
|
|
Adhesion of Tape
Good
|
12 Product change
|
22 Product change
|
9 Product change
|
|
Adhesion of Tape
Very good
|
8 Product change
|
21 Product change
|
37 Product change
|
SECONDARY outcome
Timeframe: The evaluation was carried out after 7-9 days of treatment with the test tapeSubjects 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.
Outcome measures
| Measure |
Test Product A New Adhesive Material
n=52 Product change
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Test Product B New Adhesion Material
n=49 Product change
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Comparator
n=47 Product change
The comparator product is Brava Elastic tape which is already on the market and will be used within the intended use in this clinical investigation.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
|---|---|---|---|
|
Comfort
Very discomfortable
|
2 Product change
|
3 Product change
|
0 Product change
|
|
Comfort
Discomfortable
|
5 Product change
|
5 Product change
|
2 Product change
|
|
Comfort
Acceptable
|
14 Product change
|
2 Product change
|
3 Product change
|
|
Comfort
Comfortable
|
19 Product change
|
24 Product change
|
21 Product change
|
|
Comfort
Very comfortable
|
12 Product change
|
15 Product change
|
21 Product change
|
SECONDARY outcome
Timeframe: The evaluation was carried out after 7-9 days of treatment with the test tapeSubjects will be asked if they had any skin-related complications in the area covered by the tape (yes, no).
Outcome measures
| Measure |
Test Product A New Adhesive Material
n=52 Product change
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Test Product B New Adhesion Material
n=49 Product change
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Comparator
n=47 Product change
The comparator product is Brava Elastic tape which is already on the market and will be used within the intended use in this clinical investigation.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
|---|---|---|---|
|
Skin Issues in the Area Covered by the Tape
Complications where tape was applied - Yes
|
18 Product change
|
13 Product change
|
6 Product change
|
|
Skin Issues in the Area Covered by the Tape
Complications were tape was applied- No
|
34 Product change
|
36 Product change
|
41 Product change
|
SECONDARY outcome
Timeframe: 27 daysAll Adverse Events are captured and documented throughout the study.
Outcome measures
| Measure |
Test Product A New Adhesive Material
n=12 Participants
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Test Product B New Adhesion Material
n=12 Participants
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Comparator
n=12 Participants
The comparator product is Brava Elastic tape which is already on the market and will be used within the intended use in this clinical investigation.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
|---|---|---|---|
|
Adverse Events
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Test Product A New Adhesive Material
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Test Product B New Adhesion Material
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Comparator
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product A New Adhesive Material
n=12 participants at risk
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Test Product B New Adhesion Material
n=12 participants at risk
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
Comparator
n=12 participants at risk
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.
Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Non serious adverse event
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected throughout the study period for a maximum of 27 days. If subject had on-going SAEs at termination, they were followed until the event was solved or until the subject could no longer be followed (lost to follow up). Subjects without SAEs or with terminated SAEs were not followed-up upon after the final termination visit.
|
0.00%
0/12 • Adverse event data were collected throughout the study period for a maximum of 27 days. If subject had on-going SAEs at termination, they were followed until the event was solved or until the subject could no longer be followed (lost to follow up). Subjects without SAEs or with terminated SAEs were not followed-up upon after the final termination visit.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected throughout the study period for a maximum of 27 days. If subject had on-going SAEs at termination, they were followed until the event was solved or until the subject could no longer be followed (lost to follow up). Subjects without SAEs or with terminated SAEs were not followed-up upon after the final termination visit.
|
|
Infections and infestations
Non serious adverse event
|
0.00%
0/12 • Adverse event data were collected throughout the study period for a maximum of 27 days. If subject had on-going SAEs at termination, they were followed until the event was solved or until the subject could no longer be followed (lost to follow up). Subjects without SAEs or with terminated SAEs were not followed-up upon after the final termination visit.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected throughout the study period for a maximum of 27 days. If subject had on-going SAEs at termination, they were followed until the event was solved or until the subject could no longer be followed (lost to follow up). Subjects without SAEs or with terminated SAEs were not followed-up upon after the final termination visit.
|
0.00%
0/12 • Adverse event data were collected throughout the study period for a maximum of 27 days. If subject had on-going SAEs at termination, they were followed until the event was solved or until the subject could no longer be followed (lost to follow up). Subjects without SAEs or with terminated SAEs were not followed-up upon after the final termination visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place