Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT05604456
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2022-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Secondary Ear Reconstructions Based on Nagata Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2022-10-28', 'studyFirstSubmitQcDate': '2022-11-02', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative and postoperative scores evaluated based on CNN', 'timeFrame': 'change from baseline in appearance scores at 7 months after secondary surgery', 'description': 'Preoperative and postoperative photographs were acquired for reconstructed ear evaluation of its realness and appearance improvement through convolutional neural network (CNN) models we previously developed.'}], 'secondaryOutcomes': [{'measure': 'Five-point Likert scale scores', 'timeFrame': 'at least 7 months after secondary surgery', 'description': "Five-point Likert scale score will be collected to show patient-reported outcomes in the follow-up study through questionnaires to assess patients' postoperative satisfaction. This questionnaire includes overall appearance, size, projection and subunits of the ear and the postoperative status of donor site. 1 = poor and 5 = excellent."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondary Ear Reconstructions Based on Nagata Method']}, 'referencesModule': {'references': [{'pmid': '25289252', 'type': 'BACKGROUND', 'citation': 'Long X, Yu N, Huang J, Wang X. Complication rate of autologous cartilage microtia reconstruction: a systematic review. Plast Reconstr Surg Glob Open. 2013 Nov 7;1(7):e57. doi: 10.1097/GOX.0b013e3182aa8784. eCollection 2013 Oct.'}, {'pmid': '28041938', 'type': 'BACKGROUND', 'citation': 'Akter F, Mennie JC, Stewart K, Bulstrode N. Patient reported outcome measures in microtia surgery. J Plast Reconstr Aesthet Surg. 2017 Mar;70(3):416-424. doi: 10.1016/j.bjps.2016.10.023. Epub 2016 Nov 23.'}, {'pmid': '35183463', 'type': 'BACKGROUND', 'citation': 'Ye J, Lei C, Wei Z, Wang Y, Zheng H, Wang M, Wang B. Evaluation of reconstructed auricles by convolutional neural networks. J Plast Reconstr Aesthet Surg. 2022 Jul;75(7):2293-2301. doi: 10.1016/j.bjps.2022.01.037. Epub 2022 Jan 31.'}, {'pmid': '32332549', 'type': 'BACKGROUND', 'citation': 'Reinisch JF, van Hovell Tot Westerflier CVA, Gould DJ, Tahiri YT. Secondary Salvage of the Unsatisfactory Microtia Reconstruction. Plast Reconstr Surg. 2020 May;145(5):1252-1261. doi: 10.1097/PRS.0000000000006766.'}, {'pmid': '35063805', 'type': 'BACKGROUND', 'citation': 'Yue X, Jiang H, Pan B, He L, Dong W, Yang Q. Secondary surgery for the unsatisfactory auricle after auricular reconstruction. Int J Pediatr Otorhinolaryngol. 2022 Mar;154:111043. doi: 10.1016/j.ijporl.2022.111043. Epub 2022 Jan 14.'}, {'pmid': '34481742', 'type': 'BACKGROUND', 'citation': 'Ronde EM, Esposito M, Lin Y, van Etten-Jamaludin FS, Bulstrode NW, Breugem CC. Long-term complications of microtia reconstruction: A systematic review. J Plast Reconstr Aesthet Surg. 2021 Dec;74(12):3235-3250. doi: 10.1016/j.bjps.2021.08.001. Epub 2021 Aug 17.'}, {'pmid': '17201920', 'type': 'BACKGROUND', 'citation': 'Varni JW, Limbers CA, Burwinkle TM. How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jan 3;5:1. doi: 10.1186/1477-7525-5-1.'}, {'pmid': '19451041', 'type': 'BACKGROUND', 'citation': 'Lee TS, Lim SY, Pyon JK, Mun GH, Bang SI, Oh KS. Secondary revisions due to unfavourable results after microtia reconstruction. J Plast Reconstr Aesthet Surg. 2010 Jun;63(6):940-6. doi: 10.1016/j.bjps.2009.04.016. Epub 2009 May 17.'}, {'pmid': '37924716', 'type': 'DERIVED', 'citation': 'Su XH, Ye J, Lei C, Wei SJ, Zheng HB, Shan XY, Wang B, Wang MS. Secondary ear reconstruction based on the Nagata method after unsatisfactory microtia surgery outcomes. J Plast Reconstr Aesthet Surg. 2023 Dec;87:251-258. doi: 10.1016/j.bjps.2023.10.075. Epub 2023 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to provide a feasible surgical strategy based on Nagata method for patients who require secondary revision surgeries and to verify its long-term aesthetic outcomes. The main question it aims to answer is:\n\n• Whether ear reconstruction surgery based on Nagata method can improve the unsatisfactory outcomes of primary reconstruction surgery? Participants who had accepted secondary ear reconstruction based on Nagata method in our department will be required to received questionnaires in the follow-up and their photographs will be collected for reconstructed ear evaluation of its realness through convolutional neural network (CNN) models we previously developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Microtia patients seeking for secondary ear reconstructions who had previously received reconstructive surgeries while the aesthetic outcomes were displeasing', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chest circumference larger than 60cm at the lowest sternum level;\n* Willingness to participate long-term follow-ups;\n* Ability to correctly understand the questionnaire(\\>8 years old).\n\nExclusion Criteria:\n\n* Patients with damaged superficial temporal artery (STA);\n* Patients with poor condition of rib cartilage;\n* Patients with active inflammation in auricular area;\n* Patients who refuses surgical approach.'}, 'identificationModule': {'nctId': 'NCT05604456', 'briefTitle': 'Secondary Ear Reconstructions Based on Nagata Method', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'Secondary Ear Reconstructions Based on Nagata Method for Unsatisfactory Outcomes After Microtia Surgeries', 'orgStudyIdInfo': {'id': 'SERNM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'secondary ear reconstruction based on Nagata method', 'type': 'PROCEDURE', 'description': 'Secondary auricular reconstructions based on Nagata method were conducted on patients who sought for secondary revision.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'overallOfficials': [{'name': 'Meishui Wang, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Fujian Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiaohui Su', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Physician', 'investigatorFullName': 'Xiaohui Su', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}