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NCT05604456

Secondary Ear Reconstructions Based on Nagata Method

Completed Last updated 3 November 2022
What this trial tests

trial testing secondary ear reconstruction based on Nagata method in Secondary Ear Reconstructions Based on Nagata Method in 7 participants. Completed in 1 October 2022.

Timeline
1 May 2022
Primary endpoint
1 September 2022
1 October 2022

Quick facts

Lead sponsorXiaohui Su
StatusCompleted
Study typeOBSERVATIONAL
Enrollment7
Start date1 May 2022
Primary completion1 September 2022
Estimated completion1 October 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Xiaohui Su

Who can join

8 and older, any sex, with Secondary Ear Reconstructions Based on Nagata Method. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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: • 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Secondary ear reconstruction based on the Nagata method after unsatisfactory microtia surgery outcomes.
    Su XH, Ye J, Lei C, Wei SJ, et al · · 2023 · PMID 37924716 · DOI 10.1016/j.bjps.2023.10.075

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Trials by the same sponsor.

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