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

NCT06763991 | Not Yet Recruiting DMC

• 1 other identifier: 2025-256-1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Grade-A healing

  Grade-A healing is defined as optimal wound alignment, epidermal integrity, and tight subcutaneous tissue junctions, with no significant inflammatory response or complications during recovery, and the stitches can be removed within 10 days after the operation.

  For each stage of surgery, patients are scheduled for visits about 3-6 months.

Secondary Outcomes (3)

• complication rates

  For each stage of surgery, patients are scheduled for visits about 3-6 months.

• Scar score

  3-6 months after the total ear reconstruction surgery

• Patients' satisfaction score

  3-6 months after the total ear reconstruction surgery

Study Arms (2)

First-stage Connection

ACTIVE COMPARATOR

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).

Procedure: One-stage connection

Two-stage connection

EXPERIMENTAL

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).

Procedure: Two-stage connection

Interventions

Two-stage connection 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.

Two-stage connection

One-stage connection 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.

First-stage Connection

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan provincial people's hospital

Chengdu, Sichuan, 610000, China

Location

Related Publications (1)

• Zhang X, Chen Z, Chen M, Wang Y, Du L, Cai Z, Jiang Z. Safety and efficacy of connecting the residual ear to the cartilage scaffold in the first-stage versus second-stage surgery: a protocol of a randomised controlled trial in non-expanded auricular reconstruction for concha-type microtia. BMJ Open. 2026 Feb 4;16(2):e104106. doi: 10.1136/bmjopen-2025-104106.

  PMID: 41638738 DERIVED

MeSH Terms

Conditions

Congenital Microtia

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

xinjie zhang

CONTACT

86-15881116743; zzzhangxinjie@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)