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NCT07846345From ClinicalTrials.govRecruiting

Case Management for Microtia

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

  • Congenital Microtia

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Jing Xu
Enrolment target
188
Started
1 July 2026
Main results due
31 December 2026
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Ages 6 years to 40 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

What this study is about

In the sponsor’s own words, from the registry.

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:

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.

Study sites(1)

  • EYE & ENT Hospital, Fudan University

    Shanghai, China

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07846345. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Case Management for Microtia | Trialion