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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-30
SponsorSichuan Provincial People's Hospital

About this trial

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'.

Eligibility criteria

Qualifiers

Patients were fully informed about the purpose, modalities and risks associated with this study, signed an informed consent form and were willing to be followed up.

Contrast-enhanced computed tomography (CT) scan shows he or she has 3.Patients can tolerate general anesthesia without severe chronic organic or mental illness.

Disqualifiers

Patients combined with other ear diseases such as ear fistula, titis media, etc.

Patients receive other unrelated ear surgeries during the study

Skin in the surgical area with infection, ulceration, and scarring.

Trial design

Treatments tested in this trial

  • Two-stage connection
  • One-stage connection

Treatment groups

78 Participants
are divided into 2 treatment groups