Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05298969
Status:
UNKNOWN
Last Update Posted:
2022-03-28
First Post:
2022-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temporalis Myofascial Flap Effectiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008444', 'term': 'Maxillary Sinus Neoplasms'}], 'ancestors': [{'id': 'D010255', 'term': 'Paranasal Sinus Neoplasms'}, {'id': 'D009669', 'term': 'Nose Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Assessment of temporalis myofascial flap effectiveness in reconstruction of cranio-maxillofacial defects'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of versatility of temporalis myofascial flap in reconstruction of craniomaxillofacial defects in means of flap viability, healing and epithelization', 'timeFrame': '6 months postoperatively', 'description': 'Assessment by regular follow up by pin bricks'}], 'secondaryOutcomes': [{'measure': 'Assessment of phonation and swallowing efficacy postoperatively', 'timeFrame': '6 months postoperatively', 'description': 'Assessment will be done in regular follow up visits by video fluoroscopy , trials of swallowing and phonation will be assessed by phoniatricians'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporalis flap', 'Maxillofacial defects', 'Reconstruction'], 'conditions': ['Maxillary Sinus Neoplasms']}, 'descriptionModule': {'briefSummary': "This research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with:\n\n * TMJ ankylosis\n\n * Osteomyelitis following mucormycosis\n * Following tumor resection like maxillectomy or temporal bone resection\n * Following orbital exentration due to tumors or infections\n * Following massive trauma\n * Facial reanimation\n\nExclusion Criteria:\n\n* • History of head \\& neck embolization as it may compromise blood supply of the flap\n\n * Extensive tumors involving maxillary artery\n * History of head \\& neck radiation or chemotherapy\n * Temporalis muscle wasting due to any reason\n * Bad general condition'}, 'identificationModule': {'nctId': 'NCT05298969', 'briefTitle': 'Temporalis Myofascial Flap Effectiveness', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Efficacy of Temporalis Myofascial Flap in Reconstruction of Various Cranio-maxillofacial Defects', 'orgStudyIdInfo': {'id': 'AssiutU 7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flap survival', 'description': 'Harvesting temporalis myofascial flap for cranio-maxillofacial defects', 'interventionNames': ['Procedure: Temporalis Myofascial flap']}], 'interventions': [{'name': 'Temporalis Myofascial flap', 'type': 'PROCEDURE', 'description': 'Improvement of speech and feeding quality in patients with palatal defects by temporalis myofascial flap', 'armGroupLabels': ['Flap survival']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'AssiutU7', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of ENT', 'investigatorFullName': 'Mina Youssef Asham Gendy', 'investigatorAffiliation': 'Assiut University'}}}}