Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-02 @ 6:02 AM
Study NCT ID:
NCT04906967
Status:
UNKNOWN
Last Update Posted:
2021-05-28
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sural Flap and Anterolateral Thigh Flap in Tissue Reconstruction Around the Ankle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013524', 'term': 'Surgical Flaps'}], 'ancestors': [{'id': 'D019738', 'term': 'Surgically-Created Structures'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viability of the flap', 'timeFrame': 'baseline', 'description': 'Viability of flap detected by numbers of flap survived in each group'}, {'measure': 'Size of defect covered(size of the flap)', 'timeFrame': 'Baseline', 'description': 'Detected by measuring the length and width in cms'}, {'measure': 'Resistance to infection', 'timeFrame': 'Baseline', 'description': 'Detected by numbers of flabs in each group that resist infection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Injuries']}, 'referencesModule': {'references': [{'pmid': '31785835', 'type': 'BACKGROUND', 'citation': 'Noaman HH, Soroor YO. Foot salvage using microsurgical free muscle flaps in severely crushed foot with soft tissue defects. Injury. 2019 Dec;50 Suppl 5:S17-S20. doi: 10.1016/j.injury.2019.10.040. Epub 2019 Oct 23.'}, {'pmid': '21351140', 'type': 'BACKGROUND', 'citation': 'Battiston B, Antonini A, Tos P, Daghino W, Massazza G, Riccio M. Microvascular reconstructions of traumatic-combined tissue loss at foot and ankle level. Microsurgery. 2011 Mar;31(3):212-7. doi: 10.1002/micr.20863. Epub 2011 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the outcomes of coverage of soft tissue defects of leg and foot by modified sural flap versus anterolateral thigh flap', 'detailedDescription': "The leg and foot contain a thin subcutaneous layer and few muscles, thus the tibia and tendons can easily become exposed due to trauma. Therefore leg and foot injuries are often associated with a loss of soft tissues and exposed fractures.\n\none of the following reconstructive options are chosen:\n\n1. The defect is allowed to heal by secondary intention.\n2. The wound is closed primarily.\n3. A split or full thickness skin graft and or neodermis is applied.\n4. A local random flap or propeller flap is transposed or advanced.\n5. A pedicled or island flap is transferred.\n6. A microvascular free flap is transferred. The method of soft tissue reconstruction chosen hinges on the patient's medical condition, the surgeon's experience, the size of the wound, the vascular status of the foot and the exposed structures the skin in this region has low flexibility and the subcutaneous circulation does not allow the use of long randomized flaps, the task of finding flaps to cover bones or tendons in wounds with cutaneous loss in the legs and feet is difficult.\n\nThe sural flap acts as an axial flap and has 3 sources of nutrition,the vascular plexus of the deep fascia, the medial superficial sural artery which follows the medial sural nerve and the arteries that follow the minor saphenous vein. Venous return is ensured by the minor saphenous vein which may be used as a distal pedicle to provide reverse flow.\n\nsural flap has the advantages of easy and quick harvesting without sacrificing major arteries and can be done in one stage operation.\n\nIn the other hand,Since introduction of the anterolateral thigh flap in 1984 by Song et al it has gained widespread popularity, especially in Asian countries, where it has replaced the radial forearm flap as being the workhorse in head and neck surgery.\n\nAnterolateral thigh flaps have been introduced also in lower extremity reconstruction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • patients aging 5 to 70 years.\n\n * Defect at the lower leg ,ankle or foot\n * Palpable distal pulse\n\nExclusion Criteria:\n\n* • Peripheral vascular disease\n\n * Underling bone osteomyelitis\n * Unhealthy skin of posterior or lateral aspect of leg.\n * Vascular injury.\n * Patients with chronic diseases\n * Patients associated with vital organ injuries\n * Patients unfit to surgery'}, 'identificationModule': {'nctId': 'NCT04906967', 'briefTitle': 'Sural Flap and Anterolateral Thigh Flap in Tissue Reconstruction Around the Ankle', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'A Comparative Study of Modified Sural Flap and Anterolateral Thigh Flap in Soft Tissue Reconstruction of Lower Extremity', 'orgStudyIdInfo': {'id': 'tissue coverage around ankle'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'modified sural flap', 'description': 'modified sural flap used to cover soft tissue defect around ankle', 'interventionNames': ['Procedure: flaps']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'anterolateral thigh flap', 'description': 'anterolateral thigh flap used to cover soft tissue defect around ankle', 'interventionNames': ['Procedure: flaps']}], 'interventions': [{'name': 'flaps', 'type': 'PROCEDURE', 'description': 'coverage of soft tissue defect around ankle', 'armGroupLabels': ['anterolateral thigh flap', 'modified sural flap']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ahmed faisal', 'role': 'CONTACT', 'email': 'ahmedfaysel@med.sohag.edu.eg', 'phone': '01095074338'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer in orthopedic department,faculty of medicine,sohag university,Sohag Governorate', 'investigatorFullName': 'Ahmed Faisal Esmael Mahmoud', 'investigatorAffiliation': 'Sohag University'}}}}