Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-20 @ 3:32 PM
Study NCT ID:
NCT01792557
Status:
UNKNOWN
Last Update Posted:
2014-03-24
First Post:
2013-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-21', 'studyFirstSubmitDate': '2013-02-11', 'studyFirstSubmitQcDate': '2013-02-13', 'lastUpdatePostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of time before patient returns to work/routine physical activity', 'timeFrame': '3rd month', 'description': 'Patients will be queried for when they felt comfortable to return to work and/or their routine physical activity.'}], 'primaryOutcomes': [{'measure': 'Assessment of recurrence', 'timeFrame': '3rd year', 'description': 'Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.'}], 'secondaryOutcomes': [{'measure': 'Assessment of patient comfort', 'timeFrame': '1st year', 'description': 'Patients will be queried for patient comfort at the end of first year'}, {'measure': 'Assessment of recovery duration', 'timeFrame': '3rd month', 'description': 'Post procedure wound recovery duration will be recorded'}, {'measure': 'Assessment of complications', 'timeFrame': '3rd month', 'description': 'Patients will be followed up for procedure related complications.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pilonidal sinus', 'Crystallized phenol', 'Limberg Flap', 'Modified Limberg Flap', 'Karydakis', 'Recurrence', 'Complications', 'Recovery duration', 'Time to return to work'], 'conditions': ['Pilonidal Sinus']}, 'referencesModule': {'references': [{'pmid': '15622588', 'type': 'BACKGROUND', 'citation': 'Dogru O, Camci C, Aygen E, Girgin M, Topuz O. Pilonidal sinus treated with crystallized phenol: an eight-year experience. Dis Colon Rectum. 2004 Nov;47(11):1934-8. doi: 10.1007/s10350-004-0720-y.'}, {'pmid': '20676861', 'type': 'BACKGROUND', 'citation': 'Akin M, Leventoglu S, Mentes BB, Bostanci H, Gokbayir H, Kilic K, Ozdemir E, Ferahkose Z. Comparison of the classic Limberg flap and modified Limberg flap in the treatment of pilonidal sinus disease: a retrospective analysis of 416 patients. Surg Today. 2010 Aug;40(8):757-62. doi: 10.1007/s00595-008-4098-7. Epub 2010 Jul 30.'}, {'pmid': '17305997', 'type': 'BACKGROUND', 'citation': 'Keshava A, Young CJ, Rickard MJ, Sinclair G. Karydakis flap repair for sacrococcygeal pilonidal sinus disease: how important is technique? ANZ J Surg. 2007 Mar;77(3):181-3. doi: 10.1111/j.1445-2197.2006.04003.x.'}, {'pmid': '15043735', 'type': 'BACKGROUND', 'citation': 'Cihan A, Mentes BB, Tatlicioglu E, Ozmen S, Leventoglu S, Ucan BH. Modified Limberg flap reconstruction compares favourably with primary repair for pilonidal sinus surgery. ANZ J Surg. 2004 Apr;74(4):238-42. doi: 10.1111/j.1445-2197.2004.02951.x.'}]}, 'descriptionModule': {'briefSummary': 'Although surgical techniques such as limberg flap. modified limberg flap and karydakis are currently most popular treatment methods for pilonidal disease, crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.', 'detailedDescription': 'Pilonidal sinus disease (PSD) is usually located at sacrococcygeal region of the body and mostly effect young males causing loss of labor and school time. Its incidence is reported 26 per 100000 in a Norwegian study. Although there are many treatment modalities either surgical or conservative, ideal treatment is still a matter of debate. Surgical techniques such as limberg flap, modified limberg flap and karydakis are most popular treatment methods for pilonidal disease crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We would like to compare flap techniques and crystallized phenol application for complications, recurrence, patient comfort, duration of recovery and return to work. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pilonidal disease\n\nExclusion Criteria:\n\n* Previous history of pilonidal disease treatment\n* Pregnant or breast-feeding women\n* Systemic diseases that would affect wound healing\n* Diabetes\n* Chronic renal failure\n* Autoimmune diseases\n* Malignant diseases'}, 'identificationModule': {'nctId': 'NCT01792557', 'briefTitle': 'Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'S.B. Konya Education and Research Hospital'}, 'officialTitle': 'Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'KEAH06021301'}, 'secondaryIdInfos': [{'id': 'U1111-1139-3538', 'type': 'OTHER', 'domain': 'WHO Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phenol', 'description': 'Crystallized Phenol Group', 'interventionNames': ['Drug: Crystallized phenol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Limberg', 'description': 'Limberg Flap Group', 'interventionNames': ['Procedure: Limberg Flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modified Limberg', 'description': 'Modified Limberg Flap Group', 'interventionNames': ['Procedure: Modified Limberg Flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Karydakis', 'description': 'Karydakis Flap Group', 'interventionNames': ['Procedure: Karydakis Flap']}], 'interventions': [{'name': 'Crystallized phenol', 'type': 'DRUG', 'description': 'Crystallized phenol application for pilonidal disease treatment. After sacrococcygeal region of the patient is cleaned from hairs, hairs inside the sinus are removed than crystallized phenol is applied in to the cleaned sinus. Following 2 minutes of phenol exposure, crystallized phenol is removed from the sinus. Crystallized phenol application will be repeated weekly for 4 weeks.', 'armGroupLabels': ['Phenol']}, {'name': 'Limberg Flap', 'type': 'PROCEDURE', 'description': 'Limberg Flap surgery for pilonidal disease treatment', 'armGroupLabels': ['Limberg']}, {'name': 'Modified Limberg Flap', 'type': 'PROCEDURE', 'description': 'Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area.', 'armGroupLabels': ['Modified Limberg']}, {'name': 'Karydakis Flap', 'type': 'PROCEDURE', 'description': 'Karydakis Flap surgery for pilonidal disease treatment', 'armGroupLabels': ['Karydakis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42040', 'city': 'Meram', 'state': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Konya Education and Research Hospital', 'geoPoint': {'lat': 37.82985, 'lon': 32.46777}}], 'overallOfficials': [{'name': 'Osman Doğru, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Konya Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S.B. Konya Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}