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Treatment of surgical scars in breast reduction with laser device, to prevent scar hypertrophy.

Withdrawn
Conditions
excessive scarring
hypertrophic scarring
10040795
10014982
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Withdrawn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
NameTimeMethod
<p>Outcomes of the Vancouver Scar Scale (VSS) and POSAS score at 12 months after<br /><br>surgery.</p><br>
Secondary Outcome Measures
NameTimeMethod
<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>
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