Secondary Ear Reconstructions Based on Nagata Method

Sponsor

Xiaohui Su (Other)

Overall Status

Completed

CT.gov ID

NCT05604456

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Ear Reconstructions Based on Nagata Method	Procedure: secondary ear reconstruction based on Nagata method

Study Design

Study Type:

Observational

Actual Enrollment :

7 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 1, 2022

Actual Primary Completion Date :

Sep 1, 2022

Actual Study Completion Date :

Oct 1, 2022

Outcome Measures

Primary Outcome Measures

Preoperative and postoperative scores evaluated based on CNN [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 Outcome Measures

Five-point Likert scale scores [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350000

Sponsors and Collaborators

Xiaohui Su

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Xiaohui Su, Clinical Physician, First Affiliated Hospital of Fujian Medical University

ClinicalTrials.gov Identifier:

NCT05604456

Other Study ID Numbers:

SERNM

First Posted:

Nov 3, 2022

Last Update Posted:

Nov 3, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Nov 3, 2022