Safety and Efficacy of Connecting the Residual Ear to the Cartilage Scaffold in First- vs. Second-Stage Surgery

Eligible patients will be admitted from the outpatient clinic to complete the relevant examinations after admission（Preoperative routine examination and chest CT）. The baseline parameters will be registered when admitted to hospital, including case number, diagnosis, sex, age, height, weight, and underlying medical conditions. Patients have at least 12 hours to consider participation in the study and will be given the opportunity to ask questions about the study. Written informed consent will be obtained by the surgical resident or the surgeon after admission to the hospital. Randomization will be done by relevant member . After inclusion, patients will be allocated to one of the two study groups (First-stage Connection or Second-stage Connection) using an online randomization program. The perioperative care will be the same for all included patients.Surgery will be performed by experienced surgeons, with non-expanded ear reconstruction using autologous rib cartilage. The surgery normally comprises two stages. After each surgery, details and duration of the surgery will be documented. For each stage of surgery, patients are scheduled for visits about 3-6 months. In addition, after the total surgery, patients are to fill out 'Glasgow Benefit Inventory' and 'Patient and Observer Scar Assessment Scale'.

NCT Number	NCT06763991
Lead Sponsor	Sichuan Provincial People's Hospital
Conditions	Microtia, Outcome Assessment, RCT, Surgery Related Complications Rate, Treatment Outcome, Reconstruction
Enrollment	78 participants
Start Date	2025-06-01
Primary Completion	2027-02-20 (estimated)
Study Completion	2027-02-20 (estimated)
Updated on ClinicalTrials.gov	2025-05-16