Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT01889394
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2013-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-29', 'studyFirstSubmitDate': '2013-06-24', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inability to work', 'timeFrame': '1 year', 'description': 'change for capacity for work at one year post-OP'}], 'secondaryOutcomes': [{'measure': 'Pain perioperatively and after 3 weeks', 'timeFrame': '0 and 3 weeks'}, {'measure': 'Complication rate after 3 weeks', 'timeFrame': '3 weeks'}, {'measure': 'Patient satisfaction after 3 weeks & 1year', 'timeFrame': '3 weeks and 1 year'}, {'measure': 'Recurrence rate after 1 year', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pilonidal sinus', 'excision', 'primary wound closure', 'limberg flap'], 'conditions': ['Pilonidal Sinus']}, 'descriptionModule': {'briefSummary': 'To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus.', 'detailedDescription': 'Patients who gave their informed consent who had excision of pilonidal sinus were randomly assigned to group A (primary wound closure with a Limberg flap) or to group B (open wound and p.s.wound healing).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for excision of pilonidal sinus given\n\nExclusion Criteria:\n\n* limberg flap not possible for surgical reasons'}, 'identificationModule': {'nctId': 'NCT01889394', 'briefTitle': 'Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Liestal'}, 'officialTitle': 'Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision: Short-term Results of a Randomized Controlled Multicenter Trial', 'orgStudyIdInfo': {'id': 'UKBB 234/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'limberg flap', 'description': 'primary wound closure using a limberg flap', 'interventionNames': ['Procedure: primary wound closure using a limberg flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'secondary wound healing', 'description': 'secondary wound healing', 'interventionNames': ['Procedure: secondary wound healing']}], 'interventions': [{'name': 'secondary wound healing', 'type': 'PROCEDURE', 'description': 'secondary wound healing', 'armGroupLabels': ['secondary wound healing']}, {'name': 'primary wound closure using a limberg flap', 'type': 'PROCEDURE', 'description': 'primary wound closure using a limberg flap', 'armGroupLabels': ['limberg flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Kantonsspital Liest', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}, {'city': 'Rheinfelden', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Gesundheitszentrum Fricktal', 'geoPoint': {'lat': 47.55437, 'lon': 7.79403}}, {'zip': '3930', 'city': 'Visp', 'state': 'Valais', 'country': 'Switzerland', 'facility': 'Spitalzentrum Oberwallis', 'geoPoint': {'lat': 46.2937, 'lon': 7.88149}}], 'overallOfficials': [{'name': 'Christoph A Maurer, Prof Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of General, Visceral, Vascular and Thoracic Surgery, Hospital of Liestal, Switzerland, affiliated with the University of Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Liestal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}