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

Sichuan Provincial People's Hospital

Status: Not yet enrolling

Conditions: RCT; Outcome Assessment; Reconstruction; Surgery Related Complications Rate; Microtia; Treatment Outcome

Treatments: Procedure: Two-stage connection; Procedure: One-stage connection

Study type: Interventional

Funder types: Other

Identifiers

NCT06763991

2025-256-1

Details and patient eligibility

About

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'.

Enrollment: 78 estimated patients

Sex: All

Ages: 6 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All consecutive patients between 6 and 30 years with a congenital concha-microtia8, admitted to our hospital are potentially eligible, and enrollment in the study will be based on the following criteria.

1. 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.
2. Contrast-enhanced computed tomography (CT) scan shows he or she has 3.Patients can tolerate general anesthesia without severe chronic organic or mental illness.

Exclusion criteria

1. Patients combined with other ear diseases such as ear fistula, titis media, etc.
2. Patients receive other unrelated ear surgeries during the study
3. Skin in the surgical area with infection, ulceration, and scarring.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

First-stage Connection

Active Comparator group

Description:

After obtaining written informed consent, eligible patients will be randomized with a 1:1 allocation using an online randomization module. A random number will be assigned sequentially to make sure that every patient will be randomly allocated into two groups (Accepting First-stage Connection and Second-stage Connection).

Treatment:

Procedure: One-stage connection

Two-stage connection

Experimental group

Description:

After obtaining written informed consent, eligible patients will be randomized with a 1:1 allocation using an online randomization module. A random number will be assigned sequentially to make sure that every patient will be randomly allocated into two groups (Accepting One-stage connection and Two-stage connection).

Treatment:

Procedure: Two-stage connection