women aged over 18 undergoing breast augmentation
Conditions
Interventions
Group 1: 3-D surface imaging:
Pre- and postoperative (post OP after 1-3 days, 7 days, 30 days, 90 days, 180 days, 360 days post OP) 3-D surface scans will be performed using a standardized protocol at
Sponsors
Q-Med. A Galderma Company
Galderma Laboratorium GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patient must aspire aesthetic breast and shape optimization according to the general breast variation of the normal population, exclusion of oncologic breast processes (pre OP diagnostic: mammography, ultrasound or MRI).
Exclusion criteria
Exclusion criteria: actual or older oncologic processes of the breast, acute breast infection, severe breast malformations and thoracic deformations, autoimmune or infectious diseases, fibrocystic mastopathy, pinch test < 2 cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the quantfiication of the resorption rate of Macrolane™ over 12 months at different time points (post OP after 1-3 days, 7 days, 30 days, 90 days, 180 days, 360 days post OP) by mathematically precise calculation of breast geometry, contour, shape, volume, surface and symmetry after Macrolane™ injection over time using 3-D surface imaging. The following calculations will be performed using a standardized protocol at the above named time dates: 1. linear measurements [cm] 2. breast skin surface measurement [cm²] 3. breast volume measurements [cm³] 4. evaluation of breast symmetry | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantify the degree of breast soft tissue edema after surgery | — |
Countries
Germany
Contacts
Public ContactMarkus Klöppel
Praxisklinik Dr. Markus Klöppel im MediCenter – München-Solln
Outcome results
None listed