Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-13 @ 11:22 PM
Study NCT ID:
NCT03070028
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Treatment Methods for Pilonidal Disease
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-11', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'healing time', 'timeFrame': 'first 1 year of the study', 'description': 'Time to complete closure of the sinus cavity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pilonidal Sinus']}, 'referencesModule': {'references': [{'pmid': '34629430', 'type': 'DERIVED', 'citation': 'Sevinc B, Damburaci N, Karahan O. Comparison of Curettage Plus Platelet-Rich Plasma Gel and Curettage Plus Phenol Application in Treatment of Pilonidal Sinus Disease: A Randomized Trial. Dis Colon Rectum. 2022 May 1;65(5):735-741. doi: 10.1097/DCR.0000000000002082.'}]}, 'descriptionModule': {'briefSummary': 'Patients with pilonidal sinus disease will be randomised to two groups (crystallised phenol and platelet rich plasma). Sinus healing time, patient satisfaction, complications and recurrence rates will be compared.', 'detailedDescription': 'Patients with pilonidal sinus disease will be treated by either crystallised phenol or platelet rich plasma application. Treatment results, healing time, postprocedural complications, patient satisfaction and recurrences will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having pilonidal sinus disease\n* accepting to be involved in the study\n\nExclusion Criteria:\n\n* below the age of 18\n* having connective tissue disorders\n* diabetes mellitus\n* severe anemia'}, 'identificationModule': {'nctId': 'NCT03070028', 'briefTitle': 'Minimally Invasive Treatment Methods for Pilonidal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Uşak University'}, 'officialTitle': 'Randomized Prospective Comparison of Crystallized Phenol and Platelet Rich Plasma Applications in Treatment of Pilonidal Sinus Disease', 'orgStudyIdInfo': {'id': 'PS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenol', 'description': 'crystallised phenol application', 'interventionNames': ['Procedure: crystallised phenol']}, {'type': 'EXPERIMENTAL', 'label': 'platelet rich plasma', 'description': 'PRP application', 'interventionNames': ['Procedure: Platelet rich plasma']}], 'interventions': [{'name': 'crystallised phenol', 'type': 'PROCEDURE', 'description': 'crystallised phenol will be applied to sinus cavity', 'armGroupLabels': ['Phenol']}, {'name': 'Platelet rich plasma', 'type': 'PROCEDURE', 'description': 'platelet rich plasma will be applied to sinus cavity', 'armGroupLabels': ['platelet rich plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64100', 'city': 'Uşak', 'country': 'Turkey (Türkiye)', 'facility': 'Uşak University', 'geoPoint': {'lat': 38.67351, 'lon': 29.4058}}], 'overallOfficials': [{'name': 'Barış Sevinç, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uşak University Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uşak University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant proffessor', 'investigatorFullName': 'Barış Sevinç', 'investigatorAffiliation': 'Uşak University'}}}}