NCT06763991

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

Not yet recruiting NA Last updated 16 May 2025

What this trial tests

NA trial testing Two-stage connection in Microtia in 78 participants. Not yet recruiting.

Timeline

1 June 2025

Primary endpoint
20 February 2027

20 February 2027

Quick facts

Lead sponsor	Sichuan Provincial People's Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	1 June 2025
Primary completion	20 February 2027
Estimated completion	20 February 2027
Sites	1 location across China

Drugs / interventions tested

• Two-stage connection
• One-stage connection

Conditions studied

• Microtia — all drugs for Microtia →
• Outcome Assessment — all drugs for Outcome Assessment →
• RCT — all drugs for RCT →
• Surgery Related Complications Rate — all drugs for Surgery Related Complications Rate →

Sponsor

Sichuan Provincial People's Hospital

Who can join

Adults 6 to 30, any sex, with Microtia or Outcome Assessment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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'.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Zhang X, Chen Z, Chen M, Wang Y, et al · · 2026 · PMID 41638738 · DOI 10.1136/bmjopen-2025-104106