M95.0
Conditions
Interventions
Group 1: Patients in the intervention group undergo rhinoplasty according to current standards with additional implantation of an individually tailored collagen matrix (Fibro-Gide) for soft tissue aug
Sponsors
Universitätsmedizin Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ii. Ability to provide informed consent iii. Patients have signed the informed consent form for participation in the study iv. Primary or secondary rhinoplasty with clinically and sonographically thin soft tissue coverage (= 4 mm). This threshold may be exceeded if, despite a thicker soft tissue layer, the underlying nasal framework is clearly visible and there is a clinical indication for soft tissue augmentation of the nasal dorsum. v. Patients agree and are able to comply with all study-related requirements, including attendance at follow-up visits
Exclusion criteria
Exclusion criteria: i. Immunosuppression ii. Congenital coagulation disorders iii. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT Change in soft tissue thickness of the nasal dorsum WHEN Preoperatively and postoperatively after 7 days, 6 weeks, 12 weeks, 6 months, and 12 months HOW Assessment by high-frequency ultrasound measurements at eight predefined measurement points at the nasal root, nasal dorsum, and nasal tip | — |
Secondary
| Measure | Time frame |
|---|---|
| - Patient satisfaction assessed using the Rhinoplasty Outcome Evaluation (ROE) questionnaire - Postoperative pain assessed using the QUIPS questionnaire - Postoperative symptoms and complications assessed by standardized Likert scales - Occurrence of adverse events | — |
Countries
Germany
Contacts
Public ContactRoman Rahimi-Nedjat
Universitätsmedizin Mainz
Outcome results
None listed