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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-0021 | Other Identifier | Ethics Commission of Zurich |
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Investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery plus device (Nasella) | Active Comparator | Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks. |
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| Surgery, no device thereafter | Experimental | Person in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) . |
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| Only device (Nasella) | Active Comparator | No need for surgery; use of customized nasal brace (Nasella) for nose deformities is made to improve look (cosmetic reason). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of customized nasal brace (Nasella) for nose deformities | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line). | The deviation from a perfect line (0 axis) is measured and compared to control group | 9 Weeks after surgery |
| Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip). | The deviation from a perfect line (0 axis) is measured and compared to control group | 9 Weeks after surgery |
| Broad nose: Appealing proportion of nose width to eye-corner distance. | The deviation from a perfect line (0 axis) is measured and compared to control group | 9 weeks after surgery |
| Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line). | The improvement in degrees compared to study start | 14 months of treatment with Nasella |
| Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip). | The improvement in degrees compared to study start | 14 months of treatment with Nasella |
| Broad nose: Appealing proportion of nose width to eye-corner distance. | The improvement of proportion of width compare to study start | 14 months of treatment with Nasella |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Satisfaction | 9 weeks postoperatively | |
| Subjective Satisfaction | 14 months of treatment | |
| Doctors assessment of various appearances |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silva Stutz, MSc | Contact | +41 (0)44 255 11 11 | silva.stutz@usz.ch | |
| Thomas N Roth, Dr. med. | Contact | thomas.roth@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Thomas N Roth, Dr. med. | University Hospital Zurich, Department of Otorhinolaryngology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Department of Otorhinolaryngology | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
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| corrective surgery |
| Procedure |
|
| 9 weeks postoperatively |
| Doctors assessment of various appearances | 14 months after treatment |