Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT01526967
Status:
UNKNOWN
Last Update Posted:
2012-12-17
First Post:
2012-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Evaluation of the Peristomal Skin Condition in Ostomates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada'], 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-04-22', 'releaseDate': '2014-03-19'}, {'resetDate': '2016-05-03', 'releaseDate': '2016-03-30'}], 'estimatedResultsFirstSubmitDate': '2014-03-19'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2012-02-01', 'studyFirstSubmitQcDate': '2012-02-02', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peristomal skin condition', 'timeFrame': 'At day 12', 'description': 'Change in peristomal skin condition from baseline as assessed with the SACS Instrument'}], 'secondaryOutcomes': [{'measure': 'Peristomal skin condition', 'timeFrame': 'at 1 month', 'description': 'Change in peristomal skin condition from baseline as assessed with the SACS instrument'}, {'measure': 'Level of satisfaction', 'timeFrame': 'At 2 months', 'description': 'Subjects satisfaction as measured with a satisfaction survey'}, {'measure': 'Accessory usage', 'timeFrame': 'Up to 2 months', 'description': 'Subjects use of additional products in stoma care.'}, {'measure': 'Peristomal Skin Condition', 'timeFrame': 'At 2 months', 'description': 'Change in peristomal skin condition from baseline as assessed with the SACS instrument'}, {'measure': 'Level of satisfaction', 'timeFrame': 'At 12 days', 'description': 'Subjects level of satisfaction as measured by a satisfaction survey'}, {'measure': 'Level of satisfaction', 'timeFrame': 'At 1 month', 'description': 'Subjects level of satisfaction as measured with a satisfaction survey'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ostomy', 'peristomal skin breakdown', 'ConvaTec Moldable Skin Barriers'], 'conditions': ['Ostomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'colostomates, ileostomates, urostomates in acute care settings or community at large.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are 18 years old and older.\n* Subjects who agree to participate in the evaluation and who have signed the informed consent form.\n* Subjects presenting with a stoma (ileostomy, colostomy or urostomy).\n* Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.\n\nOR\n\n* Subjects presenting with peristomal skin lesions using a traditional barrier and for whom a decision to replace the traditional barrier with ConvaTec Moldable Technology™ Skin Barrier per package insert is made in the context of routine clinical care.\n\nExclusion Criteria:\n\n* Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem.\n* Subjects who are in a simultaneous clinical evaluation.'}, 'identificationModule': {'nctId': 'NCT01526967', 'acronym': 'OSMOSE', 'briefTitle': 'Observational Evaluation of the Peristomal Skin Condition in Ostomates', 'organization': {'class': 'INDUSTRY', 'fullName': 'ConvaTec Inc.'}, 'officialTitle': 'Observational Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™ Skin Barriers', 'orgStudyIdInfo': {'id': 'MA-0509-12-U359'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'New moldable user', 'description': 'Subjects presenting with peristomal lesions with a traditional barrier and for whom a ConvaTec Moldable Technology™ Skin Barrier is used as a replacement.'}, {'label': 'New osomate', 'description': 'Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85742', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Independent Nurse Consultant', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Health Concord Campus', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '06782', 'city': 'Plymoth', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Conn. Clinical Nursing Associate, LLC'}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Home Health', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'facility': 'Porter Hospital', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'zip': '02140', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Serena Group - Dr. Thomas Serena MD', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Macomb Hospital', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Anthony's Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43222', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'ID Med Inc.', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '02860', 'city': 'Pawtucket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'RI Colorectal Clinic, LLC', 'geoPoint': {'lat': 41.87871, 'lon': -71.38256}}, {'zip': '77521', 'city': 'Baytown', 'state': 'Texas', 'country': 'United States', 'facility': 'San Jacinto Methodist Hospital', 'geoPoint': {'lat': 29.7355, 'lon': -94.97743}}, {'zip': '98055', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'NW Pavillion Ostomy Clinic', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'Qing Li, Ph.D, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'ConvaTec Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ConvaTec Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-03-19', 'type': 'RELEASE'}, {'date': '2014-04-22', 'type': 'RESET'}, {'date': '2016-03-30', 'type': 'RELEASE'}, {'date': '2016-05-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'ConvaTec Inc.'}}}}