3D surface imaging for the assessment of braest volume and breast shape changes after augmentation mammaplasty with hyaluronic acid gel (Macrolane™)
Recruiting
- Conditions
- women aged over 18 undergoing breast augmentation
- Registration Number
- DRKS00003553
- Lead Sponsor
- Q-Med. A Galderma CompanyGalderma Laboratorium GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>1. linear measurements [cm]<br>2. breast skin surface measurement [cm²]<br>3. breast volume measurements [cm³]<br>4. evaluation of breast symmetry <br>
- Secondary Outcome Measures
Name Time Method Quantify the degree of breast soft tissue edema after surgery