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A study to evaluate the effectiveness and safety of functional reconstruction of the eyelid muscle during flap grafting with nerve grafting using an allograft nerve in patients with unilateral facial paralysis.

A Single-Center, Open, Prospective and Retrospective, Controlled Comparative Study to Evaluate the Efficacy and Safety of Orbicularis Oculi Muscle Function Reconstruction Using Acellular Nerve Allograft in Functional Gracilis Muscle Flap Transfer for Patients with Unilateral Facial Paralysis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010266
Enrollment
40
Registered
2025-03-07
Start date
2025-11-06
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : The test group undergoes follow-up observation by performing surgery along with nerve trunk transplantation using acellular allogeneic nerves during functional free muscle flap tra

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults between 19 and 79 years of age 2) Patients diagnosed with House-Brackmann Grade levels 2 to 6 3) Patients eligible for functional free muscle transplantation 4) Patients with normal facial nerve function on one side

Exclusion criteria

Exclusion criteria: 1) Patients being treated for a serious infectious disease or immune disease 2) Within 2 weeks of the screening visit, patients who have used drugs that may affect the effectiveness evaluation at the discretion of the researcher, such as antithrombotic agents, steroid drugs including oral preparations and ointments, botox, fillers, etc. 3) Patients undergoing anticancer or immunosuppressant treatment 4) Patients diagnosed with bilateral facial paralysis 5) Participation in another clinical study within 2 months from the date of the screening visit (However, participation is possible if other clinical trials in which the participant participated do not affect this study at the discretion of the researcher) 6) In cases where participation in clinical research is inappropriate in the judgment of other researchers

Design outcomes

Primary

MeasureTime frame
Change in score on Facial Nerve Grading System 2.0 scale

Secondary

MeasureTime frame
Change in score on Facial Nerve Grading System 2.0 scale;Change in movement of the orbicularis oculi muscle using a 3D rendering program;Change in distance symmetry of the orbicularis oculi muscle using a 3D rendering program;Change in angular symmetry of the orbicularis oculi muscle using a 3D rendering program

Countries

Korea, Republic of

Contacts

Public ContactTaeseok Oh

Asan Medical Center

tasuko@amc.seoul.kr+82-2-3010-3607

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jun 21, 2026