Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-04 @ 1:28 PM
Study NCT ID:
NCT03424057
Status:
COMPLETED
Last Update Posted:
2018-02-06
First Post:
2018-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asymmetric Primary Closure and Additional Skin Excision Technique.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}, {'id': 'D049291', 'term': 'Seroma'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-03', 'studyFirstSubmitDate': '2018-01-30', 'studyFirstSubmitQcDate': '2018-02-03', 'lastUpdatePostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early postoperative complications.', 'timeFrame': '3 years', 'description': 'wound dehiscence, formation of seroma, hematoma, wound infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Karydakis modification', 'pilonidal sinus', 'seroma'], 'conditions': ['Pilonidal Sinus', 'Pilonidal Disease of Natal Cleft', 'Surgical Technique']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.', 'detailedDescription': 'All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.\n\nIn patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.\n\nIn patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.\n\nIn both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.\n\nPatients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients between age of 18-65 who had chronic pilonidal disease\n\nExclusion Criteria:\n\n* Patients who did not accept the procedure\n* Patients had undergone previous pilonidal sinus surgery\n* Patientshad active infection\n* Patients who were not minimum of 18 years of age'}, 'identificationModule': {'nctId': 'NCT03424057', 'briefTitle': 'Asymmetric Primary Closure and Additional Skin Excision Technique.', 'organization': {'class': 'OTHER', 'fullName': 'Siverek Devlet Hastanesi'}, 'officialTitle': 'A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.', 'orgStudyIdInfo': {'id': '74059997.050.01.04/79'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Group 1 were treated with the new technique (Asymmetric Primary Closure and Additional Skin Excision).\n\nIn this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.', 'interventionNames': ['Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Group 2 were treated with the standard Karydakis technique.', 'interventionNames': ['Procedure: Standard Karydakis technique.']}], 'interventions': [{'name': 'Asymmetric Primary Closure and Additional Skin Excision Technique', 'type': 'PROCEDURE', 'description': 'In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.', 'armGroupLabels': ['Group 1']}, {'name': 'Standard Karydakis technique.', 'type': 'PROCEDURE', 'description': 'In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method', 'armGroupLabels': ['Group 2']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'The study has been completed. The datas will be shared as an article'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siverek Devlet Hastanesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General surgeon', 'investigatorFullName': 'Abdulcabbar Kartal', 'investigatorAffiliation': 'Siverek Devlet Hastanesi'}}}}