Clinical trial NCT06763991: Safety and Efficacy of Connecting the Residual Ear to the Cartilage Scaffold in First- vs. Second-Stage Surgery
Official title: Safety and Efficacy of Connecting the Residual Ear to the Cartilage Scaffold in First- vs. Second-Stage Surgery : a Protocl of a Randomized Controlled Trial in Non-expanded Auricular Reconstruction for Concha-type Microtia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Microtia
Outcome Assessment
RCT
Surgery Related Complications Rate
Treatment Outcome
Reconstruction
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Grade-A healing
timeFrame: For each stage of surgery, patients are scheduled for visits about 3-6 months.
Secondary outcomes:
measure: complication rates
timeFrame: For each stage of surgery, patients are scheduled for visits about 3-6 months.
measure: Scar score
timeFrame: 3-6 months after the total ear reconstruction surgery
measure: Patients' satisfaction score
timeFrame: 3-6 months after the total ear reconstruction surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan provincial people's hospital
state: Sichuan
Study officials:
References: