Intelligent case management for microtia care from diagnosis through rehabilitation
Official title: Development and Application of an Intelligent Whole-course Case Management Model for Patients With Microtia
Run by Eye & ENT Hospital of Fudan University · NCT07846345 · Data updated 2026-11-12
This trial tests a mobile, intelligent case-management platform to provide continuous, personalized nursing and health guidance for people with congenital microtia undergoing ear reconstruction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 40 Years |
| Sex | All |
| Enrollment | 188 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | August 31, 2027 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07846345 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 6–40 with diagnosed congenital microtia undergoing staged ear reconstruction or related procedures at the participating centers who consent to use the digital platform.
✕Probably not a fit
Patients who do not use or benefit from the platform, or whose condition necessitates alternative care outside the platform's scope, may not experience added benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to develop and evaluate an intelligent, full‑course case-management platform for patients with congenital microtia. Phase I focuses on designing the platform through interviews, literature review, and expert input. Phase II compares outcomes between a non-randomized control group receiving routine care and an intervention group receiving platform-supported care, with assessment of health education, follow-up, and overall care experience. Eligible participants are individuals aged 6 to 40 undergoing staged ear reconstruction or related procedures at participating Shanghai institutions. No randomization is used; cohorts are enrolled sequentially to evaluate effectiveness.
Why it matters
Potential benefit: If successful, participants could experience more consistent health education, better follow-up, and a smoother care experience throughout treatment and rehabilitation.
How similar studies have gone: Prior work on digitally supported case management has shown promise in chronic and complex conditions, but this specific intelligent microtia platform represents a novel application in this surgical context.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
EYE & ENT Hospital, Fudan University
Shanghai, China Recruiting
Study contacts
- Study coordinator: Jiaying Gao
- Email: 1254091997@qq.com
- Phone: +86 13795315458
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.