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Secondary Ear Reconstructions Based on Nagata Method

Secondary Ear Reconstructions Based on Nagata Method for Unsatisfactory Outcomes After Microtia Surgeries

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05604456
Enrollment
7
Registered
2022-11-03
Start date
2022-05-01
Completion date
2022-10-01
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Ear Reconstructions Based on Nagata Method

Brief summary

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.

Interventions

PROCEDUREsecondary ear reconstruction based on Nagata method

Secondary auricular reconstructions based on Nagata method were conducted on patients who sought for secondary revision.

Sponsors

Xiaohui Su
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Chest circumference larger than 60cm at the lowest sternum level; * Willingness to participate long-term follow-ups; * Ability to correctly understand the questionnaire(\>8 years old).

Exclusion criteria

* Patients with damaged superficial temporal artery (STA); * Patients with poor condition of rib cartilage; * Patients with active inflammation in auricular area; * Patients who refuses surgical approach.

Design outcomes

Primary

MeasureTime frameDescription
Preoperative and postoperative scores evaluated based on CNNchange from baseline in appearance scores at 7 months after secondary surgeryPreoperative and postoperative photographs were acquired for reconstructed ear evaluation of its realness and appearance improvement through convolutional neural network (CNN) models we previously developed.

Secondary

MeasureTime frameDescription
Five-point Likert scale scoresat least 7 months after secondary surgeryFive-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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026