Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-28 @ 9:43 AM
Study NCT ID:
NCT05727150
Status:
UNKNOWN
Last Update Posted:
2023-02-14
First Post:
2023-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Versatility of Supraclavicular Artery Flap in Reconstruction of Head and Neck Soft Tissue Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2023-12-21', 'unreleaseDate': '2024-01-08'}, {'resetDate': '2024-06-28', 'releaseDate': '2024-01-08'}], 'estimatedResultsFirstSubmitDate': '2023-12-21'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2023-01-22', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flap Success', 'timeFrame': '6 month post-surgery', 'description': 'The flap success will be measured by percentage of patients in which there is flap survival versus percentage of patient with flap necrosis'}, {'measure': 'Flap complications', 'timeFrame': '6 months post-surgery', 'description': 'assessment of flap complication will be assessed by percentage of patients in which there is flap dehiscence , flap infection and flap necrosis'}, {'measure': 'patients satisfaction as regard flap color match', 'timeFrame': '6 months post-surgery', 'description': 'patient satisfaction as will be assessed with questionnaire'}, {'measure': 'patients satisfaction as regard flap texture match', 'timeFrame': '6 months post-surgery', 'description': 'patient satisfaction as will be assessed with questionnaire'}], 'secondaryOutcomes': [{'measure': 'Possible flap lengths', 'timeFrame': '6 months post-surgery', 'description': 'The achieved flap length will be measured in centimeters'}, {'measure': 'Possible flap widths', 'timeFrame': '6 months post-surgery', 'description': 'The achieved flap width will be measured in centimeters'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reconstruction of Head Soft Tissue Defects', 'Reconstruction of Neck Soft Tissue Defects']}, 'descriptionModule': {'briefSummary': 'This is a case series study conducted at plastic surgery department Sohag University including 20 patients The aim of this thesis is to evaluate reliability and versatility of Supraclavicular artery flap in the reconstruction of traumatic and non-traumatic defects of head and neck.With adequate documentation of functional, aesthetic outcome and patient satisfaction through; clinical examination , photographic documentation and doctor and patient satisfaction charts'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with head and neck soft tissue defect either traumatic or non-traumatic\n* Available healthy donor site\n\nExclusion Criteria:\n\n* Trauma or conditions affecting donor site or with possible compromise of vascular pedicle.\n* Patients with a major uncontrollable medical illness, chronic heavy smokers.'}, 'identificationModule': {'nctId': 'NCT05727150', 'briefTitle': 'Reliability and Versatility of Supraclavicular Artery Flap in Reconstruction of Head and Neck Soft Tissue Defects', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Reliability and Versatility of Supraclavicular Artery Flap in Reconstruction of Head and Neck Soft Tissue Defects', 'orgStudyIdInfo': {'id': 'Soh-Med-23-01-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient operated by Supraclavicular Artery flap for Reconstruction', 'description': 'Supraclavicular artery flap will be used for reconstruction', 'interventionNames': ['Procedure: Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flap']}], 'interventions': [{'name': 'Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flap', 'type': 'PROCEDURE', 'description': 'Supraclavicular artery flap will be used in the reconstruction of traumatic and non-traumatic defects of head and neck.Flap harvesting and reconstruction will be performed under general anesthesia. The defect dimensions are measured and the superficial landmarks for the supraclavicular artery are drawn .The flap will be used as island flap, transposed or interpolated flap depending on the arc of rotation needed to achieve flap inset without tension and flap elevation proceeds from lateral to medial.The flap is rotated and inset into the defect', 'armGroupLabels': ['Patient operated by Supraclavicular Artery flap for Reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmad A Albadry', 'role': 'CONTACT', 'email': 'ahmedahmed@med.sohag.edu.eg', 'phone': '201110884856'}, {'name': 'Karam A Mohammed', 'role': 'CONTACT', 'email': 'Karam.allam@med.sohag.edu.eg', 'phone': '201021777543'}], 'facility': 'Sohag Faculty of Medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Ahmad A Albadry', 'role': 'CONTACT', 'email': 'ahmedahmed@med.sohag.edu.eg', 'phone': '20111088856'}, {'name': 'Karam A Mohammed', 'role': 'CONTACT', 'email': 'karam.allam@med.sohag.edu.eg', 'phone': '201021777543'}], 'overallOfficials': [{'name': 'Ahmad A Albadry', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident,Plastic Surgery Department,Principal investigator', 'investigatorFullName': 'Ahmad Ahmad Albadry', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-21', 'type': 'RELEASE'}, {'date': '2024-01-08', 'type': 'UNRELEASE'}, {'date': '2024-01-08', 'type': 'RELEASE'}, {'date': '2024-06-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ahmad Ahmad Albadry, Resident,Plastic Surgery Department,Principal investigator, Sohag University'}}}}