Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-01 @ 10:06 AM
Study NCT ID:
NCT03200418
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2017-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Output on Newly Developed Adhesives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050762', 'term': 'Cyclin-Dependent Kinase Inhibitor p15'}, {'id': 'D019941', 'term': 'Cyclin-Dependent Kinase Inhibitor p16'}], 'ancestors': [{'id': 'D050756', 'term': 'Cyclin-Dependent Kinase Inhibitor Proteins'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D018797', 'term': 'Cell Cycle Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D025521', 'term': 'Tumor Suppressor Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-07', 'studyFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trans epidermal water loss', 'timeFrame': '8 hours', 'description': 'The trans epidermal water loss is measured on the peristomal skin using a probe. The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ileostomy - Stoma']}, 'descriptionModule': {'briefSummary': 'The study investigates the impact real output has on the adhesion of the adhesives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have given written informed consent\n2. Be at least 18 years of age and have full legal capacity\n3. Have had a stoma for more than one year\n4. Have intact skin on the area used in the evaluation\n5. Has a stoma with a diameter up to (≤) 35 mm\n6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)\n\nExclusion Criteria:\n\n1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy\n2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tab-let/injection) treatment.\n3. Are pregnant or breastfeeding\n4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)\n5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.'}, 'identificationModule': {'nctId': 'NCT03200418', 'briefTitle': 'Evaluation of the Effect of Output on Newly Developed Adhesives', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Evaluation of the Effect of Output on Newly Developed Adhesives', 'orgStudyIdInfo': {'id': 'CP265_10_11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test of new adhesives', 'description': 'On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output.\n\nThe difference between the four patches is that they consist of different adhesives.\n\nOne patch is made of a standard hydrocolloid adhesive\n\nThe primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16', 'interventionNames': ['Other: Standard hydrocolloid adhesive', 'Other: P-4', 'Other: P-15', 'Other: P-16']}], 'interventions': [{'name': 'Standard hydrocolloid adhesive', 'type': 'OTHER', 'description': 'This patch is made of standard hydrocolloid adhesive', 'armGroupLabels': ['Test of new adhesives']}, {'name': 'P-4', 'type': 'OTHER', 'description': 'This patch is made of new adhesive', 'armGroupLabels': ['Test of new adhesives']}, {'name': 'P-15', 'type': 'OTHER', 'description': 'This patch is made of new adhesive', 'armGroupLabels': ['Test of new adhesives']}, {'name': 'P-16', 'type': 'OTHER', 'description': 'This patch is made of new adhesive', 'armGroupLabels': ['Test of new adhesives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast A/S', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}