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NCT06763991 | NOT YET RECRUITING | Microtia

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

Sichuan Provincial People's Hospital

Information provided by (Responsible Party):

ξ n-order Zhang

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'.

Condition or disease

Microtia

Outcome Assessment

RCT

Surgery Related Complications Rate

Treatment Outcome

Reconstruction

Intervention/treatment

Two-stage connection

One-stage connection

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 78 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-04-20
Estimated Primary Completion Date : 2027-02-20
Estimated Study Completion Date : 2027-02-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years to 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Safety and Efficacy of Connecting the Residual Ear to the Cartilage Scaffold in First- vs. Second-Stage Surgery

Location Details

NCT06763991

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How to Participate

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Locations

Not yet recruiting

China, Sichuan

Sichuan provincial people's hospital

Chengdu, Sichuan, China, 610000