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

NCT ID: NCT06763991

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-02-20

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'.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First-stage Connection

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).

Group Type: ACTIVE_COMPARATOR

One-stage connection

Intervention Type: PROCEDURE

One-stage connection refers to a procedure that connecting and incorporating the cartilage framework with the residual ear in the first stage surgery of ear reconstruction. In one-stage surgery, the cartilage framework is connected with the residual ear (non-deformed, unexcluded part) to form a smooth and complete ear subunit structure. In this way, it is necessary to trim the excess postauricular skin, which may pose a greater risk of blood supply. After the first stage of surgery, the overall appearance of surgical ear is already roughly similar to that of a normal ear.

Two-stage connection

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).

Group Type: EXPERIMENTAL

Two-stage connection

Intervention Type: PROCEDURE

Two-stage connection refers to a procedure that connecting and incorporating the cartilage framework with the residual ear during the second stage surgery of ear reconstruction. An intact cartilage framework is embedded in skin pocket in the first stage, hence, in the second stage of surgery, parts of the cartilage framework that has already survived will be shaved off to ensure the firm combination between the residual era cartilage and grafted costal cartilage.

Interventions

Two-stage connection

Two-stage connection refers to a procedure that connecting and incorporating the cartilage framework with the residual ear during the second stage surgery of ear reconstruction. An intact cartilage framework is embedded in skin pocket in the first stage, hence, in the second stage of surgery, parts of the cartilage framework that has already survived will be shaved off to ensure the firm combination between the residual era cartilage and grafted costal cartilage.

Intervention Type: PROCEDURE

One-stage connection

One-stage connection refers to a procedure that connecting and incorporating the cartilage framework with the residual ear in the first stage surgery of ear reconstruction. In one-stage surgery, the cartilage framework is connected with the residual ear (non-deformed, unexcluded part) to form a smooth and complete ear subunit structure. In this way, it is necessary to trim the excess postauricular skin, which may pose a greater risk of blood supply. After the first stage of surgery, the overall appearance of surgical ear is already roughly similar to that of a normal ear.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xinjie Zhang

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sichuan provincial people's hospital

Chengdu, Sichuan, China

Countries

China

Central Contacts

xinjie zhang

Role: CONTACT

zzzhangxinjie@163.com

86-15881116743

Facility Contacts

liu cao

Role: primary

kejiaochu2006@126.com

86-87393318

Other Identifiers

2025-256-1

Identifier Type: -

Identifier Source: org_study_id