Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-02-13 @ 3:36 AM
Study NCT ID:
NCT02003404
Status:
COMPLETED
Last Update Posted:
2016-11-11
First Post:
2013-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jswan@lumc.edu', 'phone': '708-485-1271', 'title': 'Dr James Swan, MD', 'organization': 'Loyola University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size may not be generalizable to the population.'}}, 'adverseEventsModule': {'timeFrame': '5 months. Period from Sept 1, 2013 to Jan 31, 2014.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Abdominal Skin Barrier Peel Force', 'description': 'Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Peristomal Skin Barrier Peel Force', 'description': 'Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skin Barrier Peel Force', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Abdominal Skin Barrier Peel Force', 'description': 'Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.'}, {'id': 'OG001', 'title': 'Peristomal Skin Barrier Peel Force', 'description': 'Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'spread': '10', 'groupId': 'OG000'}, {'value': '215', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abdominal Skin Barrier Peel Force', 'description': 'Barrier materials were attached and peeled off control and peristomal abdominal skin.\n\nThree commercial barrier materials (SoftFlex, FlexWear and FlexTend) were peeled from control or peristomal abdominal skin after a set period at a set rate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All 17 participants wore all three barrier types on control area AND peristomal area NOT 34 participants in study only 17 participants in study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Abdominal Skin Barrier Peel Force', 'description': 'Three commerical barrier materials, SoftFlex, FlexWear and FlexTend barrier were peeled from control or peristomal abdominal skin after a set period at a set rate.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Must have ostomy of any type.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-05', 'studyFirstSubmitDate': '2013-11-20', 'resultsFirstSubmitDate': '2014-09-15', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-22', 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Barrier Peel Force', 'timeFrame': '4 hours', 'description': 'Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ostomy appliance'], 'conditions': ['Dermatologic Complications']}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to look at three commercially available ostomy barriers on peristomal (around the stoma) skin. Repeated barrier application and removal over years causes changes to the skin that the investigators wish to investigate. The primary objective is to measure peel force on normal skin and peel force on peristomal skin, with the intent of determining if differences occur. The study hypotheses is that no differences exist.', 'detailedDescription': 'This is a single center, non-invasive exploratory study utilizing a sample of convenience. This study compares three commercially available barrier materials on peristomal skin and normal abdominal skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ostomates with a normal peristomal skin and normal ipsilateral abdominal skin', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colostomy, Ileostomy, or Urostomy patients at least 6 months post-surgery\n* Males or females, age 18 to 80 years old at the time of enrollment\n* Body Mass Index (BMI) between 18 and 50\n* Willing to have two approximately 5" x 5" areas of the abdomen trimmed with a surgical clipper -- one in a ring around the stoma, and one on the opposite side\n* Willing to remain within the testing room for the duration of the study\n* Willing to allow a third person in the room as a witness for the duration of the study\n* Able to position oneself onto and off of the examining table without the assistance of the Investigator\n* Willing to refrain from vigorous exercise for the duration of the study\n* Willing to not take any anti-inflammatory medications (except for Tylenol/acetaminophen) starting 48 hours prior to the study and for the duration of the study\n* Willing to bring an extra barrier and replace their barrier worn during the study.\n* Willing to follow the protocol as demonstrated by signing the Informed Consent Form\n* In the opinion of the Investigator or qualified site personnel is qualified to participate\n\nExclusion Criteria:\n\n* Clinically significant diseases, which may or may not be confined to the testing site, that may contraindicate participation; including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer\n* Use of topical drugs on the application site within 1 month.\n* Use of lotions, creams, powders or oils on the application site in the 24 hours prior to application\n* Pregnancy, lactation or planning a pregnancy as determined by interview only\n* Other medical conditions, for example uncontrolled diabetes, which in the Investigator\'s judgment, makes the subject ineligible or places the subject at undue risk\n* Participation in any clinical test either using the abdomen as a test site or using systemic therapy within the previous thirty days\n* Damaged skin or other skin conditions in or near test sites which includes sunburn, scars, numerous moles or other disfiguration of the test site\n* Significant adipose tissue at the test site that would preclude adequate adhesion of the study devices\n* Known allergy to any of the test materials'}, 'identificationModule': {'nctId': 'NCT02003404', 'briefTitle': 'Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hollister Incorporated'}, 'officialTitle': 'Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin', 'orgStudyIdInfo': {'id': '5642-O'}, 'secondaryIdInfos': [{'id': 'LUHSC IRB #: 205654091813', 'type': 'OTHER', 'domain': 'Hollister Incorporated'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Abdominal Skin', 'description': 'Apply SoftFlex (standard wear commercial skin barrier), FlexWear (standard wear commercial skin barrier), and FlexTend (extended wear commercial skin barrier), material to non-peristomal abdominal skin.', 'interventionNames': ['Device: Control Abdominal Skin']}, {'label': 'Peristomal Abdominal Skin', 'description': 'Apply SoftFlex, FlexWear and FlexTend barrier material to peristomal abdominal skin.', 'interventionNames': ['Device: Peristomal Abdominal Skin']}], 'interventions': [{'name': 'Control Abdominal Skin', 'type': 'DEVICE', 'otherNames': ['SoftFlex', 'FlexWear', 'FlexTend'], 'description': 'Three barrier materials will be peeled from abdominal skin after a set period at a set rate.', 'armGroupLabels': ['Control Abdominal Skin']}, {'name': 'Peristomal Abdominal Skin', 'type': 'DEVICE', 'otherNames': ['SoftFlex', 'FlexWear', 'FlexTend'], 'description': 'Three barrier materials will be peeled from abdominal skin after a set period at a set rate.', 'armGroupLabels': ['Peristomal Abdominal Skin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60526', 'city': 'La Grange Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'La Grange Center for Health', 'geoPoint': {'lat': 41.83475, 'lon': -87.86173}}], 'overallOfficials': [{'name': 'James Swan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loyola University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hollister Incorporated', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Loyola University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}