Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-29 @ 3:55 PM
Study NCT ID:
NCT02224404
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2014-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Hilde.Beele@uzgent.be', 'phone': '09/332 22 87', 'title': 'Dr. Hilde Beele', 'organization': 'Universitair Ziekenhuis Gent'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fast Gelling Dressing', 'description': 'Fast Gelling Dressing (Exufiber)', 'otherNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Periwound redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fast Gelling Dressing', 'description': 'Fast Gelling Dressing (Exufiber)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'the subjects will be measured by the following variables; maceration,', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fast Gelling Dressing', 'description': 'Fast Gelling Dressing (Exufiber)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fast Gelling Dressing', 'description': 'Fast Gelling Dressing (Exufiber)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fast Gelling Dressing', 'description': 'Fast Gelling Dressing (Exufiber)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '19.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2014-08-21', 'resultsFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2014-08-22', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-25', 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)', 'timeFrame': '6 weeks', 'description': 'the subjects will be measured by the following variables; maceration,'}], 'secondaryOutcomes': [{'measure': "Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance", 'timeFrame': '6 weeks', 'description': 'Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pressure Ulcers']}, 'descriptionModule': {'briefSummary': 'The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Both gender ≥18 years old.\n2. Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP)\n3. Exuding pressure ulcer\n4. Signed Informed Consent.\n\nExclusion Criteria:\n\n1. Known allergy/hypersensitivity to the dressing.\n2. Infected wounds, (2 signs of infection/local inflammation and a positive swab)\n3. Stage 1 PU\n4. Dry wounds\n5. Subjects who will have problems following the protocol\n6. Subjects included in other ongoing clinical investigation at present or during the past 30 days'}, 'identificationModule': {'nctId': 'NCT02224404', 'briefTitle': 'Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended', 'organization': {'class': 'INDUSTRY', 'fullName': 'Molnlycke Health Care AB'}, 'officialTitle': 'Open, Non-comparative, Multi-centre Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended', 'orgStudyIdInfo': {'id': 'CHEXU02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fast Gelling Dressing', 'interventionNames': ['Device: Fast Gelling Dressing (Exufiber)']}], 'interventions': [{'name': 'Fast Gelling Dressing (Exufiber)', 'type': 'DEVICE', 'armGroupLabels': ['Fast Gelling Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8500', 'city': 'Kortrijk', 'state': 'Kortrijk', 'country': 'Belgium', 'facility': 'Dermatologie Campus Kennedylaan', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Dep. of Plastic Surgery UZ Bruzzel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000 Gent', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Gent, Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '00260', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Töölö Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Hilde Beele, prof. dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Gent, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molnlycke Health Care AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}