Stoma Site Leakage
Conditions
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.
Interventions
DEVICETest product A
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
DEVICETest product B
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
DEVICEComparator
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Adherent Area Measured by Photo of Used Tape | 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
| Measure | Time frame | Description |
|---|---|---|
| Erythema Measured After Each Treatment Period by Spectrophotometric Method | The measurements were carried out after 7-9 days of treatment with the test tape | 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. |
| Erythema Measured After Tape Removal by Photos | The measurements were carried out after 7-9 days of treatment with the test tape | 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. |
| Feeling of Security | The evaluation was carried out after 7-9 days of treatment with the test tape | 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. |
| Adhesion of Tape | The evaluation was carried out after 7-9 days of treatment with the test 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. |
| Skin Issues in the Area Covered by the Tape | The evaluation was carried out after 7-9 days of treatment with the test tape | Subjects will be asked if they had any skin-related complications in the area covered by the tape (yes, no). |
| Adverse Events | 27 days | All Adverse Events are captured and documented throughout the study. |
| Comfort | The evaluation was carried out after 7-9 days of treatment with the test tape | 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. |
Countries
Denmark
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 2 |
| 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. | 2 |
| 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. | 2 |
| 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. | 2 |
| 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. | 2 |
| Total | 12 |
Baseline characteristics
| Characteristic | Total | Test Tape A, Test Tape B, and Then Comparator Tape | Comparator Tape, Test Tape A and Then Test Tape B | Comparator Tape, Test Tape B and Then Test Tape A | Test Tape A, Comparator Tape and Then Test Tape B | Test Tape B, Comparator Tape and Then Test Tape A | Test Tape B, Test Tape A and Then Comparator Tape |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Continuous | 61.1 years STANDARD_DEVIATION 17.4 | 52.5 years STANDARD_DEVIATION 26.2 | 71.5 years STANDARD_DEVIATION 6.4 | 42.5 years STANDARD_DEVIATION 30.4 | 71 years STANDARD_DEVIATION 0 | 63 years STANDARD_DEVIATION 19.8 | 66 years STANDARD_DEVIATION 0 |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — | — | — |
| Region of Enrollment Denmark | 12 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 1 / 12 | 1 / 12 | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
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.
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Product A New Adhesive Material | Mean Adherent Area Measured by Photo of Used Tape | 46.54 Cm2 | Standard Deviation 1.23 |
| Test Product B New Adhesion Material | Mean Adherent Area Measured by Photo of Used Tape | 51.61 Cm2 | Standard Deviation 1.24 |
| Comparator | Mean Adherent Area Measured by Photo of Used Tape | 52.94 Cm2 | Standard Deviation 1.24 |
Secondary
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.
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test Product A New Adhesive Material | Adhesion of Tape | Good | 12 Product change |
| Test Product A New Adhesive Material | Adhesion of Tape | Acceptable | 16 Product change |
| Test Product A New Adhesive Material | Adhesion of Tape | Very poor | 5 Product change |
| Test Product A New Adhesive Material | Adhesion of Tape | Poor | 11 Product change |
| Test Product A New Adhesive Material | Adhesion of Tape | Very good | 8 Product change |
| Test Product B New Adhesion Material | Adhesion of Tape | Acceptable | 6 Product change |
| Test Product B New Adhesion Material | Adhesion of Tape | Very poor | 0 Product change |
| Test Product B New Adhesion Material | Adhesion of Tape | Poor | 0 Product change |
| Test Product B New Adhesion Material | Adhesion of Tape | Good | 22 Product change |
| Test Product B New Adhesion Material | Adhesion of Tape | Very good | 21 Product change |
| Comparator | Adhesion of Tape | Very good | 37 Product change |
| Comparator | Adhesion of Tape | Good | 9 Product change |
| Comparator | Adhesion of Tape | Very poor | 0 Product change |
| Comparator | Adhesion of Tape | Acceptable | 1 Product change |
| Comparator | Adhesion of Tape | Poor | 0 Product change |
Secondary
Adverse Events
All Adverse Events are captured and documented throughout the study.
Time frame: 27 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Product A New Adhesive Material | Adverse Events | 1 Participants |
| Test Product B New Adhesion Material | Adverse Events | 1 Participants |
| Comparator | Adverse Events | 1 Participants |
Secondary
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.
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test Product A New Adhesive Material | Comfort | Comfortable | 19 Product change |
| Test Product A New Adhesive Material | Comfort | Acceptable | 14 Product change |
| Test Product A New Adhesive Material | Comfort | Very discomfortable | 2 Product change |
| Test Product A New Adhesive Material | Comfort | Discomfortable | 5 Product change |
| Test Product A New Adhesive Material | Comfort | Very comfortable | 12 Product change |
| Test Product B New Adhesion Material | Comfort | Acceptable | 2 Product change |
| Test Product B New Adhesion Material | Comfort | Very discomfortable | 3 Product change |
| Test Product B New Adhesion Material | Comfort | Discomfortable | 5 Product change |
| Test Product B New Adhesion Material | Comfort | Comfortable | 24 Product change |
| Test Product B New Adhesion Material | Comfort | Very comfortable | 15 Product change |
| Comparator | Comfort | Very comfortable | 21 Product change |
| Comparator | Comfort | Comfortable | 21 Product change |
| Comparator | Comfort | Very discomfortable | 0 Product change |
| Comparator | Comfort | Acceptable | 3 Product change |
| Comparator | Comfort | Discomfortable | 2 Product change |
Secondary
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.
Time frame: The measurements were carried out after 7-9 days of treatment with the test tape
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product A New Adhesive Material | Erythema Measured After Each Treatment Period by Spectrophotometric Method | 10.1 Unitless | Standard Deviation 2.6 |
| Test Product B New Adhesion Material | Erythema Measured After Each Treatment Period by Spectrophotometric Method | 10.0 Unitless | Standard Deviation 3 |
| Comparator | Erythema Measured After Each Treatment Period by Spectrophotometric Method | 11.0 Unitless | Standard Deviation 3.7 |
Secondary
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.
Time frame: The measurements were carried out after 7-9 days of treatment with the test tape
Population: One subject from treatment-arm 6 is missing from the analysis as the photo material of the subject was insufficient for assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Product A New Adhesive Material | Erythema Measured After Tape Removal by Photos | Middle degree of skin reaction | 1 Participants |
| Test Product A New Adhesive Material | Erythema Measured After Tape Removal by Photos | Lowest degree of skin reaction | 6 Participants |
| Test Product A New Adhesive Material | Erythema Measured After Tape Removal by Photos | Highest degree of skin reaction | 4 Participants |
| Test Product B New Adhesion Material | Erythema Measured After Tape Removal by Photos | Middle degree of skin reaction | 4 Participants |
| Test Product B New Adhesion Material | Erythema Measured After Tape Removal by Photos | Lowest degree of skin reaction | 6 Participants |
| Test Product B New Adhesion Material | Erythema Measured After Tape Removal by Photos | Highest degree of skin reaction | 1 Participants |
| Comparator | Erythema Measured After Tape Removal by Photos | Lowest degree of skin reaction | 3 Participants |
| Comparator | Erythema Measured After Tape Removal by Photos | Highest degree of skin reaction | 6 Participants |
| Comparator | Erythema Measured After Tape Removal by Photos | Middle degree of skin reaction | 2 Participants |
Secondary
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.
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test Product A New Adhesive Material | Feeling of Security | Good | 15 Product change |
| Test Product A New Adhesive Material | Feeling of Security | Acceptable | 14 Product change |
| Test Product A New Adhesive Material | Feeling of Security | Very poor | 3 Product change |
| Test Product A New Adhesive Material | Feeling of Security | Poor | 9 Product change |
| Test Product A New Adhesive Material | Feeling of Security | Very good | 11 Product change |
| Test Product B New Adhesion Material | Feeling of Security | Acceptable | 2 Product change |
| Test Product B New Adhesion Material | Feeling of Security | Very poor | 0 Product change |
| Test Product B New Adhesion Material | Feeling of Security | Poor | 0 Product change |
| Test Product B New Adhesion Material | Feeling of Security | Good | 25 Product change |
| Test Product B New Adhesion Material | Feeling of Security | Very good | 22 Product change |
| Comparator | Feeling of Security | Very good | 29 Product change |
| Comparator | Feeling of Security | Good | 14 Product change |
| Comparator | Feeling of Security | Very poor | 0 Product change |
| Comparator | Feeling of Security | Acceptable | 4 Product change |
| Comparator | Feeling of Security | Poor | 0 Product change |
Secondary
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).
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test Product A New Adhesive Material | Skin Issues in the Area Covered by the Tape | Complications where tape was applied - Yes | 18 Product change |
| Test Product A New Adhesive Material | Skin Issues in the Area Covered by the Tape | Complications were tape was applied- No | 34 Product change |
| Test Product B New Adhesion Material | Skin Issues in the Area Covered by the Tape | Complications where tape was applied - Yes | 13 Product change |
| Test Product B New Adhesion Material | Skin Issues in the Area Covered by the Tape | Complications were tape was applied- No | 36 Product change |
| Comparator | Skin Issues in the Area Covered by the Tape | Complications where tape was applied - Yes | 6 Product change |
| Comparator | Skin Issues in the Area Covered by the Tape | Complications were tape was applied- No | 41 Product change |