Secondary Ear Reconstructions Based on Nagata Method

November 2, 2022 updated by: Xiaohui Su

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • The First Affiliated Hospital of Fujian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Microtia patients seeking for secondary ear reconstructions who had previously received reconstructive surgeries while the aesthetic outcomes were displeasing

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative and postoperative scores evaluated based on CNN
Time Frame: change from baseline in appearance scores at 7 months after secondary surgery
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.
change from baseline in appearance scores at 7 months after secondary surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Five-point Likert scale scores
Time Frame: at least 7 months after secondary surgery
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.
at least 7 months after secondary surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaohui Su

Investigators

  • Study Chair: Meishui Wang, Master, First Affiliated Hospital of Fujian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SERNM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Secondary Ear Reconstructions Based on Nagata Method

Clinical Trials on secondary ear reconstruction based on Nagata method

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe