Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-03 @ 2:18 AM
Study NCT ID:
NCT01841567
Status:
COMPLETED
Last Update Posted:
2014-09-30
First Post:
2013-04-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Market Clinical Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kourosh.zarghooni@uk-koeln.de', 'phone': '+49 2247887294', 'title': 'Dr Kourosh Zarghooni', 'organization': 'Klinik und Poliklinik für Orthopädie und Unfallchirurgie der Uniklinik Köln'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dressing', 'description': 'Mepilex border post. op\n\nMepilex border post op', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': '•Cardiac disorders', 'notes': 'suspicion of heart attack, no relation to the study product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'surgical and medical procedures', 'notes': 'reoperation due to implantdislocation, no relation to the study product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Minimize the Risk of the Development of Blistering.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dressing', 'description': 'Mepilex border post. op\n\nMepilex border post op'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'Number of participants without blisters at study visit', 'unitOfMeasure': 'participants'}, {'type': 'SECONDARY', 'title': "Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dressing', 'description': 'Mepilex border post. op\n\nMepilex border post op'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery', 'unitOfMeasure': 'participants'}, {'type': 'SECONDARY', 'title': 'Comfort, Comformability, Acceptability of the Dressing', 'timeFrame': '7 days'}, {'type': 'SECONDARY', 'title': 'Pain Evaluation', 'timeFrame': '7 days'}, {'type': 'SECONDARY', 'title': 'Overall Cost Regarding Dressing Wear Time', 'timeFrame': '7 days'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dressing', 'description': 'Mepilex border post. op\n\nMepilex border post op'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dressing', 'description': 'Mepilex border post. op\n\nMepilex border post op'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '11.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-26', 'studyFirstSubmitDate': '2013-04-23', 'resultsFirstSubmitDate': '2014-04-16', 'studyFirstSubmitQcDate': '2013-04-25', 'lastUpdatePostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-26', 'studyFirstPostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimize the Risk of the Development of Blistering.', 'timeFrame': '7 days', 'description': 'Number of participants without blisters at study visit'}], 'secondaryOutcomes': [{'measure': "Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.", 'timeFrame': '7 days', 'description': 'The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery'}, {'measure': 'Comfort, Comformability, Acceptability of the Dressing', 'timeFrame': '7 days'}, {'measure': 'Pain Evaluation', 'timeFrame': '7 days'}, {'measure': 'Overall Cost Regarding Dressing Wear Time', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hip', 'knee'], 'conditions': ['Hip or Knee Surgery']}, 'descriptionModule': {'briefSummary': 'The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Age 45 years\n2. Have an expected total length of stay of 4 or more days\n3. Undergoing elective primary arthroplasty of the hip or knee\n4. Undergoing hip surgery with a standard access\n5. Give their written informed consent to participate\n\nExclusion Criteria\n\n1. Dressing size does not fit the incision area\n2. Known allergy hypersensitivity to any of the components of the dressing\n3. Multi-trauma\n4. Undergoing arthroplasty due to tumour\n5. Fractures\n6. Wound at the surgical site prior to surgery\n7. Neurological deficit of operated side\n8. Subject has documented skin disease at time of enrolment, as judged by the investigator\n9. Previously enrolled in the present investigation\n10. Subject included in other ongoing investigation at present, as judged by the investigator.'}, 'identificationModule': {'nctId': 'NCT01841567', 'acronym': 'MxB Po01', 'briefTitle': 'Post Market Clinical Follow-up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Molnlycke Health Care AB'}, 'officialTitle': 'A Multi-centre, Post CE-mark, Open Investigation to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'MxB Po01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'dressing', 'interventionNames': ['Device: Mepilex border post. op', 'Device: Mepilex border post op']}], 'interventions': [{'name': 'Mepilex border post. op', 'type': 'DEVICE', 'armGroupLabels': ['dressing']}, {'name': 'Mepilex border post op', 'type': 'DEVICE', 'armGroupLabels': ['dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50924', 'city': 'Cologne', 'state': 'Köln', 'country': 'Germany', 'facility': 'universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Kourosh Zarghooni, Dr. Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Koln'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molnlycke Health Care AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}