None listed
Conditions
Interventions
Medical Device : In this study, patients requiring rhinoplasty with silicone implant insertion will be randomly assigned in a 1:1 ratio to either the test group, undergoing rhinoplasty using a silicon
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged 20 to 65 years at the time of providing written informed consent. 2.Patients scheduled to undergo rhinoplasty (augmentation rhinoplasty) involving silicone implant insertion for cosmetic or reconstructive purposes. 3.Patients with no history of plastic surgery or trauma-related surgery in the nasal area within the past 1 year (primary rhinoplasty patients are prioritized). 4.Patients who have received a thorough explanation of the study’s purpose, methods, and potential risks from the investigator, and who voluntarily sign the informed consent form in person. 5.Patients who are capable of adhering to scheduled follow-up visits (at 4 weeks and 24 weeks postoperatively) and completing all required examinations during the 24-week follow-up period.
Exclusion criteria
Exclusion criteria: 1.Patients with active bacterial, fungal, or viral infections, or severe inflammatory skin diseases at the planned surgical site (nasal and surrounding tissues). 2.Patients considered unable to undergo normal wound healing due to immunocompromised status resulting from high-dose steroid use, immunosuppressive therapy, chemotherapy, type 1 diabetes, or severe autoimmune diseases. 3.Patients at extremely high risk of capsular contracture due to pre-existing severe fibrosis, soft-tissue defects, or extensive scarring caused by frequent previous nasal surgeries or severe history of infection. 4.Patients with anatomical deformities unsuitable for ultrasound examination, or those in whom high-frequency ultrasound evaluation is impossible or restricted due to gel allergies or related conditions. 5.Pregnant or lactating female patients, or women planning a pregnancy during the study period. 6.Patients currently participating in another clinical trial/study, or those for whom less than 30 days have elapsed since completing another trial. 7.Patients with insufficient clinical records or photographic data for comparative analysis, or those deemed by the investigator to be unsuitable for smooth follow-up or whose safety may be compromised.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of capsular thickness using high-frequency ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blinded Evaluation of Clinical Capsular Contracture and External Deformity ;Evaluation using non-contrast facial 3D Computed Tomography (3D CT).;Global Aesthetic Improvement Scale (GAIS) Assessment;Patient Satisfaction Assessment (VAS);Incidence of Adverse Events (AEs) | — |
Countries
Korea, Republic of
Contacts
Public ContactJONG WOO CHOI
Asan Medical Center
Outcome results
None listed