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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product A new adhesive material | Experimental | 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 B new adhesion material | Experimental | 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. |
|
| Comparator | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product A | Device | one new adhesive material which is applied to the baseplate and the subjects peristomal skin |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonny Karlsmark, MD | Bispebjerg hospital, Dermato-Venerologisk afdeling. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg hospital | Copenhagen | Copenhagen NV | 2400 | Denmark |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One subject from treatment arm 6 did not complete the questionnaires related to secondary endpoints
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | Standard Deviation | Cm2 | 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 |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product A New Adhesive Material | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non serious adverse event | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Erosion of peristomal skin |
One subject missed completing questionnaire related to secondary end points for Test Tape A and Comparator Tape and one subject was included in the study despite treatment with steroid cream of pyoderma ulcers. The treatment was close to being completed and was assessed by investigator as a deviation that had no impact on the rights, safety and well-being of the subject or that could impact the scientific outcome of the investigation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Scientific Affairs | Coloplast A/S | +45 4911 1111 | clinicaltrialsgovSA@coloplast.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2020 | Jan 27, 2021 | Prot_SAP_000.pdf |
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| Test product B | Device | one new adhesive material which is applied to the baseplate and the subjects peristomal skin |
|
| Comparator | Device | Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal 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 |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Test Product B New Adhesion Material | 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 |
| OG002 | Comparator | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | Unitless | The measurements were carried out after 7-9 days of treatment with the test tape |
|
|
|
| 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. | One subject from treatment-arm 6 is missing from the analysis as the photo material of the subject was insufficient for assessment. | Posted | Count of Participants | Participants | The measurements were carried out after 7-9 days of treatment with the test tape |
|
|
|
| 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. | Posted | Count of Units | Product change | The evaluation was carried out after 7-9 days of treatment with the test tape | Product change | Product change |
|
|
|
| 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. | Posted | Count of Units | Product change | The evaluation was carried out after 7-9 days of treatment with the test tape | Product change | Product change |
|
|
|
| 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. | Posted | Count of Units | Product change | The evaluation was carried out after 7-9 days of treatment with the test tape | Product change | 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). | Posted | Count of Units | Product change | The evaluation was carried out after 7-9 days of treatment with the test tape | Product change | Product change |
|
|
|
| Secondary | Adverse Events | All Adverse Events are captured and documented throughout the study. | Posted | Count of Participants | Participants | 27 days |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Test Product B New Adhesion Material | 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 | 0 | 12 | 0 | 12 | 1 | 12 |
| EG002 | Comparator | 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 | 0 | 12 | 0 | 12 | 1 | 12 |
|
| Non serious adverse event | Infections and infestations | Non-systematic Assessment | Parodontitis Spicalis |
|
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Highest degree of skin reaction |
|
| Acceptable |
|
| Good |
|
| Very good |
|
| Acceptable |
|
| Good |
|
| Very good |
|
| Acceptable |
|
| Comfortable |
|
| Very comfortable |
|