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

Launched by SICHUAN PROVINCIAL PEOPLE'S HOSPITAL · Jan 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different stages of surgery for patients with a condition called microtia, which affects the outer ear's shape and size. Researchers want to see if connecting the remaining part of the ear to a cartilage framework during the first stage of surgery is safe and effective compared to doing this connection in the second stage. The trial will involve patients aged 6 to 30 who meet specific criteria, such as being able to have general anesthesia and not having other ear infections or conditions.

Participants in the study will first be evaluated to ensure they meet the eligibility requirements. If they agree to join, they will be randomly assigned to one of the two surgery groups. Everyone will receive the same level of care before, during, and after the surgery, which will be performed by experienced surgeons. After each surgery, patients will have follow-up visits, and they will be asked to fill out surveys about their experience and the results. The trial is not yet recruiting participants, but it aims to provide valuable insights into improving ear reconstruction techniques.

Gender

ALL

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.