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OpenTrials
Completed

NCT Number: NCT05604456

Secondary Ear Reconstructions Based on Nagata Method

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.

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Key information

Conditions

Secondary Ear Reconstructions Based on Nagata Method

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

secondary ear reconstruction based on Nagata method

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Xiaohui Su

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2022
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.