Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-02 @ 2:36 AM
Study NCT ID:
NCT06885450
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perforator Pedicled V-Y Advanced Flaps for Coverage in the Lower Limbs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'flaps observation', 'timeFrame': '12-24months', 'description': 'flaps color ,temperature ,with or without effusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['the lower leg', 'soft tissue defects', 'perforator flaps', 'dopper ultrasound', 'advanced flaps'], 'conditions': ['Soft Tissue Defects', 'Perforator Flap']}, 'referencesModule': {'references': [{'pmid': '23616252', 'type': 'BACKGROUND', 'citation': 'Choi JW, Nam SY, Choi SH, Roh JL, Kim SY, Hong JP. Applications of medial sural perforator free flap for head and neck reconstructions. J Reconstr Microsurg. 2013 Sep;29(7):437-42. doi: 10.1055/s-0033-1343959. Epub 2013 Apr 24.'}, {'pmid': '29922552', 'type': 'BACKGROUND', 'citation': 'Mendieta M, Cabrera R, Siu A, Altamirano R, Gutierrez S. Perforator Propeller Flaps for the Coverage of Middle and Distal Leg Soft-tissue Defects. Plast Reconstr Surg Glob Open. 2018 May 2;6(5):e1759. doi: 10.1097/GOX.0000000000001759. eCollection 2018 May.'}]}, 'descriptionModule': {'briefSummary': 'Repair of soft tissue defects with hardware exposing in the lower limbs was considered as a severe challenge for plastic surgeons in reconstructive surgery. The purpose of the paper was to investigate the clinical effect of perforator pedicled V-Y advanced flap for repairing soft tissue defects with hardware exposing in the lower leg .', 'detailedDescription': 'The various causes of the lower leg defects always consist of trauma, infection, tumors etc. Flaps are often used to cover the wounds when the bones and tendons are exposed to the body surface. However, flap coverage at the lower leg was considered a severe challenge due to the difficult anatomy and paucity of soft tissue1. Reconstruction and esthetic aspects of defect should be systemically considered .Common skin flaps include the peroneal perforator flap, the medial sural artery perforator flap2-8and muscle flaps. However, common skin flaps have a disadvantage of reversing of the pedicle which may be a reason of necrosis. A split thickness skin graft was usually applied to cover close secondary wound at the donor site. The aim of this paper was to investigate the clinical effect of V-Y advanced flaps based on septocutaneous and musculocutaneous perforator in the repair of soft-tissue wounds in the lower limbs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From April 2018 to August 2020, patients were hospitalized in the Department of Burns and Plastic Surgery of a regional hospital. All damages referred to the lower leg and soft tissue defects', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. people age: among 5-80years,\n2. tolerate general anesthesia.\n3. The perforating vessel is fine.\n\nExclusion Criteria:\n\n1. patients age :\\<5years,\\>80years\n2. can not tolerate general anesthesia.\n3. The perforating vessel is damaged -'}, 'identificationModule': {'nctId': 'NCT06885450', 'briefTitle': 'Perforator Pedicled V-Y Advanced Flaps for Coverage in the Lower Limbs', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Xuzhou Medical University'}, 'officialTitle': 'Perforator Pedicled V-Y Advanced Flaps for Coverage of Soft Tissue Defects in the Lower Limbs', 'orgStudyIdInfo': {'id': 'XYFY-SSZX'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Perforator Pedicled Flaps', 'type': 'PROCEDURE', 'description': 'Perforator Pedicled V-Y Advanced Flaps'}]}, 'contactsLocationsModule': {'locations': [{'zip': '221000', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'overallOfficials': [{'name': 'the affiliated hospital of xuzhou medical university', 'role': 'STUDY_CHAIR', 'affiliation': 'The Affiliated Hospital of Xuzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}