Nasal deformities in adults
Conditions
Interventions
Experimental Group:Nasal deformity repair
Sponsors
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 (including the threshold), gender not limited; 2. Those with nasal deformities or defects caused by congenital or acquired injuries, and who have the need for nasal deformity correction and repair; 3. Voluntarily participate in this clinical trial and sign the informed consent form for subjects.
Exclusion criteria
Exclusion criteria: 1. Those who have undergone previous rhinoplasty or related surgeries; 2. Those with abundant sebaceous glands on the nose, rosacea or obvious skin inflammation on the nose; 3. Those with infection foci on the face or all over the body; 4. People with keloid-prone constitution; 5. People with diabetes and poor blood sugar control (glycated hemoglobin >8.5%); 6. Those with abnormal liver or kidney function during the screening period (AST, ALT or Cr > 1.5 times the upper limit of the normal value) and with clinical significance; 7. Those with platelet counts lower than 50×10^9/L or abnormal coagulation mechanisms (APTT > 1.5 times the upper limit of the normal value) during the screening period and with clinical significance; 8. Those with severe cardiovascular or circulatory system diseases who have been determined by researchers to be intolerant to surgery; 9. Those with concurrent malignant tumors; 10. Those with a history of autoimmune diseases such as rheumatism or lupus erythematosus, or with immune dysfunction; 11. Those who are in an unstable mental state or have doubts about filling materials; 12. Those who have a history of allergy to silk fibroin materials and anesthetic drugs, or have an allergic constitution (allergic to two or more substances); 13. Pregnant or lactating women, and those planning to become pregnant during the trial period; 14. Those who have participated in other interventional device clinical trials or in drug clinical trials within the last five half-lives of the last use within one month prior to the conduct of this trial; 15. Other individuals who the researchers consider unsuitable for participating in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasal cartilage morphological repair effect at 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of the Nasal and Paranasal Sinus Outcome Test-22 (SNOT-22) scale;Structural stability of rhinoplasty;Score of the Rhinoplasty Outcome Assessment Scale (ROE);NOSE Symptom Checklist (NOSE) score;Improvement of nasal ventilation function;Analyze the three-dimensional contour of the nose through three-dimensional digital images;GAIS score for blind researchers;The morphological repair effect of nasal cartilage after surgery; | — |
Countries
China
Contacts
Public ContactMin Yao
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed