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Congenital MicrotiaNCT07846345

Case Management for Microtia

A study testing Microtia case-management platform in people with Congenital Microtia, run by Jing Xu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to develop an intelligent, full-course case management model for patients with microtia, enabling them to receive continuous, individualized nursing and health management services across the stages from diagnosis and treatment to rehabilitation. Read more about this study

Who is it for?
Ages 6 to 40 years
Conditions the study is for
Congenital Microtia
What is being tested?
Microtia case-management platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteChina
Study dates
1 Jul 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Aged 6-40 years
  • Meeting the diagnostic criteria for microtia as defined in Plastic Surgery of China, presenting typical microtia morphology and undergoing auricular reconstruction
  • Patients undergoing staged total ear reconstruction (including first-stage framework placement and ear elevation) or expander-based total ear reconstruction (expander implantation and semi-covered technique); temporoparietal fascia flap surgery; external auditory canal surgery

Who cannot join

  • Abnormal coagulation or other laboratory findings
  • Absence of normal fascial coverage of the affected ear, or presence of eczema, infection or other local pathology on the affected side
  • Severe cognitive impairment or psychiatric disorders
  • Concomitant major organ dysfunction
  • Refusal by the patient or family to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiaying Gao contact

+86 13795315458

1254091997@qq.com

China1 site, 1 recruiting

  • EYE & ENT Hospital, Fudan University

    Shanghai, 201112

    Jing Xu, +86 34233106, xujing10126@163.com

    Recruiting

Other trials in China

About this study

Official title: Development and Application of an Intelligent Whole-course Case Management Model for Patients With Microtia

The aim of this study is to develop an intelligent, full-course case management model for patients with microtia, enabling them to receive continuous, individualized nursing and health management services across the stages from diagnosis and treatment to rehabilitation.

The study seeks to address the following questions:

Read more

What practical needs do patients with microtia and their families have throughout the treatment process? How can case management and an information-based platform be used to provide continuous, personalized health management for these patients? Does implementation of an intelligent case management model improve patient health education, follow-up management and care experience?

What will participants be asked to do? During microtia-related diagnosis and treatment,

Participants will:

Establish a personal health record documenting disease- and treatment-related information; Receive stage-specific, individualized health education and nursing guidance; Obtain treatment reminders, follow-up notifications and rehabilitation tasks via an information platform; Complete corresponding health management tasks under the guidance of healthcare professionals; Communicate online with healthcare providers through the platform and provide timely feedback on treatment and rehabilitation; Undergo scheduled follow-up and outcome assessments. Through these procedures, the research team will integrate patients' fragmented needs for diagnosis, treatment, nursing and rehabilitation at different stages, forming a continuous management process that spans the entire course of care.

Read the detailed description

This study comprises two phases. In phase I, a case-management platform for patients with microtia will be developed. Semi-structured interviews with patients, family members, plastic surgeons, anaesthesiologists, clinical nurses and social workers, together with a literature review and expert meetings, will be conducted to inform platform design. Phase II is the effectiveness evaluation. Patients admitted for ear reconstruction surgery at the Eye, Ear, Nose and Throat Hospital of Fudan University between January and June 2026 will be assigned to the control group and receive routine care. Patients admitted between July and December 2026 will be assigned to the intervention group and receive care supported by the microtia case-management platform. Recruitment for the intervention cohort will begin after completion of control cohort enrolment, with no overlap. No randomisation will be performed. Primary and secondary outcomes will be compared between the two cohorts.

Being tested
Microtia case-management platform
Keywords
Congenital microtia, whole-course care, case management, mobile health, intelligent nursing
Medical subject headings
Congenital Microtia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microtia case-management platformOther

    An intelligent, whole-course case-management model will be implemented for patients with microtia. Continuous electronic health records will be established, and stage-specific individualized health education, rehabilitation guidance and follow-up tasks will be provided. The platform will enable health information updates, task check-ins, message-based communication and online follow-up.

Study groups in NCT07846345
Study groupRoleWhat they receive
Control groupNo interventionThe control group will receive standard care according to current departmental practice, including routine perioperative nursing, conventional health education, discharge guidance and standard follow-up, without use of the intelligent case-management platform.
Intervention groupExperimentalIn addition to standard care, the intervention group will use the microtia case-management platform.
Receives: Other: Microtia case-management platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of postoperative complications after ear reconstruction

    This study includes common complications after ear reconstruction, namely haematoma, infection, flap necrosis, framework exposure and pressure injury. The incidence of postoperative complications is calculated as: incidence = (number of patients with complications / total number of patients) × 100%.

    Measured: Assessed 3 months postoperatively

Secondary outcomes (6)

  1. Health education awareness rate

    A self-developed questionnaire on health education awareness will be used. The questionnaire covers eight domains: postoperative disease knowledge, diet, precautions for postoperative activity, postoperative medication, catheter- and pain-related education, postoperative wound observation and discharge health education. Each item has three response options (aware, partly aware, and unaware), with "partly aware" and "unaware" both classified as unaware. Health education awareness rates will be calculated for the control and intervention groups using the formula: health education awareness rate = (number of unaware items / total number of items) × 100%.

    Measured: Assessed 1 day before discharge

  2. Patients' anxiety symptoms

    The Screen for Child Anxiety Related Emotional Disorders (SCARED) is a self-report instrument for children and adolescents that assesses anxiety disorders across five factors: somatic/panic, generalized anxiety, separation anxiety, social phobia and school phobia. It comprises 41 items, each rated on a three-point scale from 0 to 2 (0: not true; 1: somewhat true; 2: very true). Higher scores indicate more severe anxiety.

    Measured: Assessed 1 month after discharge

  3. Caregivers' anxiety symptoms

    SAS is used to assess the subjective experience of anxiety and consists of 20 items, each scored on a four-point scale. Five items are positively worded (items 5, 9, 13, 17 and 19), and 15 items are negatively worded (all remaining items). Family members of patients are assessed using the SAS: scores <50 indicate no anxiety, 50-59 mild anxiety, 60-69 moderate anxiety and >69 severe anxiety. Higher scores denote greater anxiety severity. In this study, the SAS is used to evaluate anxiety in patients aged 16 years or older and their caregivers.

    Measured: Assessed 1 month after discharge

  4. Patient follow-up rate

    The follow-up rates of patients in the control and intervention groups at 1 and 3 months after discharge were calculated as: patient follow-up rate = (number of patients who actually participated in follow-up / total number of patients scheduled for follow-up) × 100%.

    Measured: Assessed at 1 and 3 months after discharge

  5. Quality of life of patients

    Quality of life was assessed using the Quality of Life Scale for Patients with Congenital Middle and External Ear Malformation. This scale evaluates three dimensions-physical functioning, psychological status and social relationships-with 18 items in total. Each item is scored on a five-point scale from 0 to 4; higher scores indicate poorer quality of life.

    Measured: Assessed 1 month after discharge

  6. Patient satisfaction

    Evaluated using a self-designed satisfaction questionnaire comprising 15 items across five domains: consultation process and environment, quality of medical and nursing services, attitude of medical and nursing staff, health education and use of the information platform. Each item is rated on a three-point Likert scale (3 = satisfied, 2 = basically satisfied, 1 = dissatisfied), yielding a total score of 15-45. The sum of item scores represents overall satisfaction, with higher scores indicating greater patient satisfaction.

    Measured: Assessed 1 month after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start1 Jul 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07846345
Sponsor's protocol ID
Case management for microtia
Status last verified
Sep 2026
First submitted
23 Sep 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with external researchers due to patient privacy protection and institutional data policy. Aggregated study results will be reported in publications.

Publications

  • Perera S, Dabney BW. Case management service quality and patient-centered care. J Health Organ Manag. 2020 Jun 24;ahead-of-print(ahead-of-print). doi: 10.1108/JHOM-12-2019-0347.

    PubMed 32584524

  • Zhou Y, Li X, Zhang M, Lv G, Duan B, Tang Z. Effect of Multimedia Health Education on Psychological Burden, Quality of Life Ability, and Self-Efficacy of Congenital Microtia. Comput Math Methods Med. 2022 Aug 11;2022:1482865. doi: 10.1155/2022/1482865. eCollection 2022.

    PubMed 35991152

  • Kim HAJ, Namavarian A, Khan U, Levy BB, Ziai H, Talei B, Gantous AM. Reconstructive Techniques in Pediatric Congenital Microtia: A Systematic Review and Meta-analysis. Facial Plast Surg. 2025 Apr;41(2):204-211. doi: 10.1055/a-2247-5109. Epub 2024 Jan 17.

    PubMed 38232751

  • Torres I, Martinez JDC, Sanabria R, Gonzalez LV, Diaz-Baez D. Postoperative Safety and Satisfaction in Patients With Microtia. J Oral Maxillofac Surg. 2021 Feb;79(2):472.e1-472.e9. doi: 10.1016/j.joms.2020.09.004. Epub 2020 Sep 8.

    PubMed 33010219

  • Asirova GV, Wynands J, Almeida DL. Improvement of Quality of Life After Microtia Reconstruction Using a Modified Firmin Technique-Case Series of 130 Patients. Aesthetic Plast Surg. 2025 Jul;49(13):3528-3537. doi: 10.1007/s00266-025-04697-z. Epub 2025 Feb 7.

    PubMed 39920383

  • Hilewitz D, Olshinka A. Early Non-Surgical Treatment For Microtia Types 1 and 2. J Craniofac Surg. 2024 Jul-Aug 01;35(5):1509-1512. doi: 10.1097/SCS.0000000000010279. Epub 2024 May 14.

    PubMed 38743060

  • Patel KR, Benchetrit L, Ronner EA, Occhiogrosso J, Hadlock T, Shaye D, Quesnel AM, Cohen MS. Development of an interdisciplinary microtia-atresia care model: A single-center 20-year experience. Laryngoscope Investig Otolaryngol. 2022 Nov 16;7(6):2103-2111. doi: 10.1002/lio2.896. eCollection 2022 Dec.

    PubMed 36544952

  • Turhan Damar H, Ogce Aktas F. Anxiety, Depression, Stress, and Self-Esteem in Turkish Parents of Children with Microtia. Cleft Palate Craniofac J. 2024 Dec;61(12):1981-1990. doi: 10.1177/10556656231190046. Epub 2023 Jul 24.

    PubMed 37488938

  • Reinisch JF, van Hovell Tot Westerflier CVA, Gould DJ, Tahiri YT. Secondary Salvage of the Unsatisfactory Microtia Reconstruction. Plast Reconstr Surg. 2020 May;145(5):1252-1261. doi: 10.1097/PRS.0000000000006766.

    PubMed 32332549

  • Fan Y, Liu W, Fan X, Niu X, Chen X. Psychosocial status of patients with unilateral and bilateral microtia before auricular reconstruction surgery. Int J Pediatr Otorhinolaryngol. 2021 Dec;151:110928. doi: 10.1016/j.ijporl.2021.110928. Epub 2021 Sep 25.

    PubMed 34607045

  • Deng K, Dai L, Yi L, Deng C, Li X, Zhu J. Epidemiologic characteristics and time trend in the prevalence of anotia and microtia in China. Birth Defects Res A Clin Mol Teratol. 2016 Feb;106(2):88-94. doi: 10.1002/bdra.23462. Epub 2015 Dec 17.

    PubMed 26681129

  • Luquetti DV, Heike CL, Hing AV, Cunningham ML, Cox TC. Microtia: epidemiology and genetics. Am J Med Genet A. 2012 Jan;158A(1):124-39. doi: 10.1002/ajmg.a.34352. Epub 2011 Nov 21.

    PubMed 22106030

  • Li Q, Zhou X, Wang Y, Qian J, Zhang Q. Auricular reconstruction of congenital microtia by using the modified Nagata method: Personal 10-Year experience with 1350 cases. J Plast Reconstr Aesthet Surg. 2018 Oct;71(10):1462-1468. doi: 10.1016/j.bjps.2018.05.036. Epub 2018 Jun 19.

    PubMed 30097399

  • Behrens B, Swetlitz C, Pine DS, Pagliaccio D. The Screen for Child Anxiety Related Emotional Disorders (SCARED): Informant Discrepancy, Measurement Invariance, and Test-Retest Reliability. Child Psychiatry Hum Dev. 2019 Jun;50(3):473-482. doi: 10.1007/s10578-018-0854-0.

    PubMed 30460424

  • Dunstan DA, Scott N, Todd AK. Screening for anxiety and depression: reassessing the utility of the Zung scales. BMC Psychiatry. 2017 Sep 8;17(1):329. doi: 10.1186/s12888-017-1489-6.

    PubMed 28886698

Questions about this trial

What is this clinical trial studying?

A study testing Microtia case-management platform in people with Congenital Microtia, run by Jing Xu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiaying Gao (+86 13795315458, 1254091997@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative complications after ear reconstruction (time frame: Assessed 3 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07846345, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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