Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
Study NCT ID:
NCT04544566
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2020-06-26
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialsgovSA@coloplast.com', 'phone': '+45 4911 1111', 'title': 'Head of Scientific Affairs', 'organization': 'Coloplast A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Test Product A New Adhesive Material', 'description': '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.\n\nTest product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nComparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test Product B New Adhesion Material', 'description': '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.\n\nTest product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nComparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Comparator', 'description': '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.\n\nTest product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nComparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Non serious adverse event', 'notes': 'Erosion of peristomal skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non serious adverse event', 'notes': 'Parodontitis Spicalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Adherent Area Measured by Photo of Used Tape', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product A New Adhesive Material', 'description': '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.\n\nTest product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nComparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG001', 'title': 'Test Product B New Adhesion Material', 'description': '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.\n\nTest product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nComparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG002', 'title': 'Comparator', 'description': '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.\n\nTest product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin\n\nComparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin'}], 'classes': [{'categories': [{'measurements': [{'value': '46.54', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '51.61', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '52.94', 'spread': '1.24', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', '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', 'description': '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.', 'unitOfMeasure': 'Cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Erythema Measured After Each Treatment Period by Spectrophotometric Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product A New Adhesive Material', 'description': 'Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG001', 'title': 'Test Product B New Adhesion Material', 'description': 'Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG002', 'title': 'Comparator', 'description': 'Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The measurements were carried out after 7-9 days of treatment with the test tape', 'description': '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.', 'unitOfMeasure': 'Unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Erythema Measured After Tape Removal by Photos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product A New Adhesive Material', 'description': 'Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG001', 'title': 'Test Product B New Adhesion Material', 'description': 'Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG002', 'title': 'Comparator', 'description': 'Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin'}], 'classes': [{'categories': [{'title': 'Lowest degree of skin reaction', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Middle degree of skin reaction', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Highest degree of skin reaction', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The measurements were carried out after 7-9 days of treatment with the test tape', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject from treatment-arm 6 is missing from the analysis as the photo material of the subject was insufficient for assessment.'}, {'type': 'SECONDARY', 'title': 'Feeling of Security', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'units': 'Product change', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product A New Adhesive Material', 'description': 'Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG001', 'title': 'Test Product B New Adhesion Material', 'description': 'Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG002', 'title': 'Comparator', 'description': 'Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin'}], 'classes': [{'categories': [{'title': 'Very poor', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Poor', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Acceptable', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Good', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}, {'title': 'Very good', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'The evaluation was carried out after 7-9 days of treatment with the test tape', 'description': '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.', 'unitOfMeasure': 'Product change', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Product change', 'denomUnitsSelected': 'Product change'}, {'type': 'SECONDARY', 'title': 'Adhesion of Tape', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'units': 'Product change', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product A New Adhesive Material', 'description': 'Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG001', 'title': 'Test Product B New Adhesion Material', 'description': 'Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG002', 'title': 'Comparator', 'description': 'Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin'}], 'classes': [{'categories': [{'title': 'Very poor', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Poor', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Acceptable', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Good', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': 'Very good', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'The evaluation was carried out after 7-9 days of treatment with the test tape', 'description': '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.', 'unitOfMeasure': 'Product change', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Product change', 'denomUnitsSelected': 'Product change'}, {'type': 'SECONDARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'units': 'Product change', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product A New Adhesive Material', 'description': 'Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG001', 'title': 'Test Product B New Adhesion Material', 'description': 'Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG002', 'title': 'Comparator', 'description': 'Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin'}], 'classes': [{'categories': [{'title': 'Very discomfortable', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Discomfortable', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Acceptable', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Comfortable', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}, {'title': 'Very comfortable', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'The evaluation was carried out after 7-9 days of treatment with the test tape', 'description': '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.', 'unitOfMeasure': 'Product change', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Product change', 'denomUnitsSelected': 'Product change'}, {'type': 'SECONDARY', 'title': 'Skin Issues in the Area Covered by the Tape', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'units': 'Product change', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product A New Adhesive Material', 'description': 'Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG001', 'title': 'Test Product B New Adhesion Material', 'description': 'Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG002', 'title': 'Comparator', 'description': 'Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin'}], 'classes': [{'categories': [{'title': 'Complications where tape was applied - Yes', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Complications were tape was applied- No', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'The evaluation was carried out after 7-9 days of treatment with the test tape', 'description': 'Subjects will be asked if they had any skin-related complications in the area covered by the tape (yes, no).', 'unitOfMeasure': 'Product change', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Product change', 'denomUnitsSelected': 'Product change'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tape A', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin'}, {'id': 'OG001', 'title': 'Test Tape B', 'description': '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.\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.'}, {'id': 'OG002', 'title': 'Comparator Tape', 'description': '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.\n\nThe 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 intended use in this clinical investigation.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '27 days', 'description': 'All Adverse Events are captured and documented throughout the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Tape A, Test Tape B, and Then Comparator Tape', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'FG001', 'title': 'Test Tape A, Comparator Tape and Then Test Tape B', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'FG002', 'title': 'Comparator Tape, Test Tape A and Then Test Tape B', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'FG003', 'title': 'Comparator Tape, Test Tape B and Then Test Tape A', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'FG004', 'title': 'Test Tape B, Comparator Tape and Then Test Tape A', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'FG005', 'title': 'Test Tape B, Test Tape A and Then Comparator Tape', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Tape A, Test Tape B, and Then Comparator Tape', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'BG001', 'title': 'Test Tape A, Comparator Tape and Then Test Tape B', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'BG002', 'title': 'Comparator Tape, Test Tape A and Then Test Tape B', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'BG003', 'title': 'Comparator Tape, Test Tape B and Then Test Tape A', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'BG004', 'title': 'Test Tape B, Comparator Tape and Then Test Tape A', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'BG005', 'title': 'Test Tape B, Test Tape A and Then Comparator Tape', 'description': '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.\n\nTest product A: one new adhesive material was applied to the baseplate and the subjects peristomal skin\n\nTest product B: one new adhesive material was applied to the baseplate and the subjects peristomal skin.\n\nThe 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.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '52.5', 'spread': '26.2', 'groupId': 'BG000'}, {'value': '71', 'spread': '0', 'groupId': 'BG001'}, {'value': '71.5', 'spread': '6.4', 'groupId': 'BG002'}, {'value': '42.5', 'spread': '30.4', 'groupId': 'BG003'}, {'value': '63', 'spread': '19.8', 'groupId': 'BG004'}, {'value': '66', 'spread': '0', 'groupId': 'BG005'}, {'value': '61.1', 'spread': '17.4', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One subject from treatment arm 6 did not complete the questionnaires related to secondary endpoints'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-11', 'size': 659822, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-27T10:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-13', 'studyFirstSubmitDate': '2020-06-26', 'resultsFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-13', 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Adherent Area Measured by Photo of Used Tape', 'timeFrame': 'Tapestrips per test product were removed from the baseplate at each product change and saved for the next site visit every 7-9 days for evaluation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Erythema Measured After Each Treatment Period by Spectrophotometric Method', 'timeFrame': 'The measurements were carried out after 7-9 days of treatment with the test tape', 'description': '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.'}, {'measure': 'Erythema Measured After Tape Removal by Photos', 'timeFrame': 'The measurements were carried out after 7-9 days of treatment with the test tape', 'description': '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.'}, {'measure': 'Feeling of Security', 'timeFrame': 'The evaluation was carried out after 7-9 days of treatment with the test tape', 'description': '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.'}, {'measure': 'Adhesion of Tape', 'timeFrame': 'The evaluation was carried out after 7-9 days of treatment with the test tape', 'description': '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.'}, {'measure': 'Comfort', 'timeFrame': 'The evaluation was carried out after 7-9 days of treatment with the test tape', 'description': '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.'}, {'measure': 'Skin Issues in the Area Covered by the Tape', 'timeFrame': 'The evaluation was carried out after 7-9 days of treatment with the test tape', 'description': 'Subjects will be asked if they had any skin-related complications in the area covered by the tape (yes, no).'}, {'measure': 'Adverse Events', 'timeFrame': '27 days', 'description': 'All Adverse Events are captured and documented throughout the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stoma Site Leakage']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has given written informed consent\n* Be at least 18 years of age and have full legal capacity\n* Have had a stoma for more than ½ year\n* Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).\n* Willing to change baseplate every second day or less frequent\n* Willing to avoid using Concave baseplate during the study.\n* Willing to avoid the use of barrier creams or similar that affect the skin/adhesive interface under the tape.\n\nExclusion Criteria:\n\n* Currently receiving or have within the past 2 months received radio-and/or chemotherapy\n* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet(injection) treatment\n* Is pregnant or breastfeeding\n* Having dermatological problems in the peristomal area (assessed by investigator)'}, 'identificationModule': {'nctId': 'NCT04544566', 'briefTitle': 'A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin', 'orgStudyIdInfo': {'id': 'CP319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test product A new adhesive material', 'description': '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.', 'interventionNames': ['Device: Test product A', 'Device: Test product B', 'Device: Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Test product B new adhesion material', 'description': '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.', 'interventionNames': ['Device: Test product A', 'Device: Test product B', 'Device: Comparator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': '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.', 'interventionNames': ['Device: Test product A', 'Device: Test product B', 'Device: Comparator']}], 'interventions': [{'name': 'Test product A', 'type': 'DEVICE', 'description': 'one new adhesive material which is applied to the baseplate and the subjects peristomal skin', 'armGroupLabels': ['Comparator', 'Test product A new adhesive material', 'Test product B new adhesion material']}, {'name': 'Test product B', 'type': 'DEVICE', 'description': 'one new adhesive material which is applied to the baseplate and the subjects peristomal skin', 'armGroupLabels': ['Comparator', 'Test product A new adhesive material', 'Test product B new adhesion material']}, {'name': 'Comparator', 'type': 'DEVICE', 'description': 'Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin', 'armGroupLabels': ['Comparator', 'Test product A new adhesive material', 'Test product B new adhesion material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Bispebjerg hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Tonny Karlsmark, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg hospital, Dermato-Venerologisk afdeling.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}