Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT02593604
Status:
COMPLETED
Last Update Posted:
2017-10-12
First Post:
2015-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2015-04-11', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life (WHOQOL-BREF)', 'timeFrame': '2 years postop', 'description': 'Quality of Life is checked by WHOQOL-BREF'}, {'measure': 'Quality of Life (DLQI)', 'timeFrame': '2 years postop', 'description': 'Quality of Life is checked by DLQI'}, {'measure': 'Quality of Life (FLQA-d)', 'timeFrame': '2 years postop', 'description': 'Quality of Life is checked by FLQA-d'}, {'measure': 'Quality of Life (Skindex)', 'timeFrame': '2 years postop', 'description': 'Quality of Life is checked by Skindex'}], 'secondaryOutcomes': [{'measure': 'Sexual Function', 'timeFrame': '2 years postop', 'description': 'Sexual Function is checked by IIEF (male) and FSFI (female)'}, {'measure': 'Demographic Parameters', 'timeFrame': '2 years postop', 'description': "Patients' history"}, {'measure': 'Smoking', 'timeFrame': '2 years postop', 'description': 'Smoking'}, {'measure': 'Weight and height', 'timeFrame': '2 years postop', 'description': 'Weight and height'}, {'measure': 'Wound assessment', 'timeFrame': '2 years postop', 'description': 'Localization, Hurley Stage, pain before operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hidradenitis suppurativa', 'Wide excision', 'Quality of Life', 'Sexual Function'], 'conditions': ['Hidradenitis Suppurativa', 'Wide Excision']}, 'descriptionModule': {'briefSummary': 'Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI, Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hidradenitis suppurativa that were treated in 2013 in Fachklinik Hornheide, Germany, by wide excision of their infected skin areas.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hidradenitis suppurativa that was wide excised in 2013 in Fachklinik Hornheide\n* Agreed to retrospective analysis and questionnaires\n\nExclusion Criteria:\n\n* Non-compliance'}, 'identificationModule': {'nctId': 'NCT02593604', 'briefTitle': 'Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': '14-015'}, 'secondaryIdInfos': [{'id': 'U1111-1176-0162', 'type': 'OTHER', 'domain': 'WHO'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'University of Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Tobias Kisch, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Schleswig-Holstein, Campus Lübeck, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fachklinik Hornheide an der Universität Münster', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tobias Kisch', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}