Treatment of surgical scars in breast reduction with laser device, to prevent scar hypertrophy.
Withdrawn
- Conditions
- excessive scarringhypertrophic scarring1004079510014982
- Registration Number
- NL-OMON36674
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
- Patients undergoing breast reduction surgery with a wise pattern technique.
- Older than 18 years of age.
- Willing to participate.
Exclusion Criteria
- Dark skin (skin types V or VI, Fitzpatrick Skin Typing Test)
- Pregnant woman
- Malignant tumor skin disease
- Bacterial or viral infectious skin disease
- Immunosuppression (linked to a pathology or specific treatment)
- BMI > 27
- Hart and/or lung disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Outcomes of the Vancouver Scar Scale (VSS) and POSAS score at 12 months after<br /><br>surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Objective scar measures: volume (3D), width, height, colour.<br /><br>Cosmetic appearance. The patient will rate the scar*s overall cosmetic aspect<br /><br>on a visual analogue scale. Two independent plastics surgeons will rate the<br /><br>overall aspect as well on basis of the photographs.<br /><br>Complications.<br /><br>Time course of scar formation using all parameter measures at earlier time<br /><br>points (10 days, 6 weeks, 3 and 6 months after surgery).</p><br>