Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT04974918
Status:
UNKNOWN
Last Update Posted:
2021-08-09
First Post:
2021-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Reliability and Versatility of Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-11-07', 'releaseDate': '2023-01-24'}], 'estimatedResultsFirstSubmitDate': '2023-01-24'}}}, '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': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-01', 'studyFirstSubmitDate': '2021-07-16', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of donor site scar', 'timeFrame': 'one year', 'description': 'the possibility of a one-stage reconstruction and customization. In addition, the use of this flap increases aesthetic results, as it uses a local flap and conceals the donor scar within a natural fold.\n\nprevent furthur operations for reconstructions. We use( 0..100 visual analog scale) to show change of skin texture to basal line as 0 is the worst result and 100 the best ...patient questionnaire about the result will be done'}], 'secondaryOutcomes': [{'measure': 'change of lip size', 'timeFrame': 'one year', 'description': 'as other procedures may cause microstomia and affect speech'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lip Injury']}, 'referencesModule': {'references': [{'pmid': '32168126', 'type': 'RESULT', 'citation': 'Ercan A, Ercan LD, Demiroz A. Nasolabial Perforator Flap: A Multi-Tool for Reconstruction of Facial Units. J Craniofac Surg. 2020 Jun;31(4):1042-1045. doi: 10.1097/SCS.0000000000006285.'}]}, 'descriptionModule': {'briefSummary': 'Nasolabial flaps have limited mobility and may need two stages, mostly for intraoral defects .The facial artery perforator-based flap is the first true perforator flap in the face. It allows one-stage reconstruction and allows freedom in flap design.\n\nThe nasolabial perforator flap has certain advantages such as repair using a similar tissue, a wider rotation arc around the pedicle compared to the other regional flaps, and the primary closure of the donor area.', 'detailedDescription': 'Recently, perforator flaps have become popular in many areas of reconstructive surgery. They provide design freedom and reduce donor-site morbidity. Many traditional local flaps including nasolabial flaps are based on the use of the axial facial artery with multiple perforators. Flaps based on one perforator of the facial artery have been introduced and are used more frequently because of their advantages over perforator flaps.\n\nAccording to recent literatures, facial artery provides numerous cutaneous perforators, on which skin flaps can be islanded, with greater mobility and liability for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage. .\n\nMultiple perforators along the facial artery, a mean of 4 on each half of the face (range: 2-8), with a mean diameter of 0.94 mm (range: 0.53-1.36 mm) and maximum perforators between 20 and 60 mm from the origin along the length of the facial artery. This roughly corresponds to an area near the angle of the mouth around the nasolabial fold. A local skin flap based on such perforators can be islanded, with greater freedom in flap designing for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage Ethical consideration This study will be approved by the ethics committee of Faculty of Medicine Sohag University. A written informed consent will be taken from every patient that will be included in this study and all patients will be informed about the nature \\& the aim of the study and the possibility of any complication.\n\nSurgical technique:\n\nAfter tumor ablation the facial artery perforator along the nasolabial fold was found and marked with a handheld Doppler probe. A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement. For protection against shear forces, the investigators left a small cuff of subcutaneous fat around the perforator'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lip defect more than half of lip\n* Patients aging 7 to 70 years\n\nExclusion Criteria:\n\n* Lip defect less than half of lip\n* Patients with a major uncontrollable medical illness, chronic heavy smokers'}, 'identificationModule': {'nctId': 'NCT04974918', 'briefTitle': 'The Reliability and Versatility of Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip Defects', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'The Reliability and Versatility of Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip Defects', 'orgStudyIdInfo': {'id': 'Soh-Med-21-07-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip defects', 'description': 'participants will be chosen according to liable age and information will be given about complications', 'interventionNames': ['Procedure: Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.']}], 'interventions': [{'name': 'Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.', 'type': 'PROCEDURE', 'description': 'A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement.', 'armGroupLabels': ['Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip defects']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aya Ahmed Ahmed, resident', 'role': 'CONTACT', 'email': 'aya.abdelmawgod@med.sohag.edu.eg', 'phone': '01125473647'}, {'name': 'Ahmed Gaber Ahmed, MD', 'role': 'CONTACT', 'phone': '01062580587'}], 'overallOfficials': [{'name': 'Gamal Yossef Elsayed, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'sohag university , Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at plastic surgery sohag university hospital', 'investigatorFullName': 'Aya Ahmed Ahmed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-01-24', 'type': 'RELEASE'}, {'date': '2023-11-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Aya Ahmed Ahmed, resident doctor at plastic surgery sohag university hospital, Sohag University'}}}}