Stromal Vascular Fraction injectable as a preventive treatment of scars.

Completed

Conditions: Hypertrophic skin
mammareduction
prevention of scars
10040795

Registration Number: NL-OMON47353

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- Females
- Aged 18-60
- Mamma reduction in both mammae, wise pattern

Exclusion Criteria

- Male
- Aged below 18 or above 60 years
- Surgical interventions of the breasts in the year prior to the date of surgery
- Mammareduction of 1 mamma
- Any oncological event in the patients history
- A known psychiatric condition
- A known systemic disease that will impair wound healing (e.g. diabetes mellitus, known atherosclerosis with an event that required hospitalization, collagen diseases, diseases of the skin)
- Smoking
- Prednisone or other immunotherapy
- Pregnancy or active child wish
- Frequent exposure to known carcinogenic substances (e.g. work related).
- Active or previous use of hormone replacement therapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postoperative clinical improvement is measured with the patient part of the<br /><br>POSAS questionnaire and will focus on: vascularization, pigmentation,<br /><br>thickness, relief, pliability, pain, itchiness, stiffness and irregularity.<br /><br>Questionnaires will be given at predetermined time-points (6 months and 1 year<br /><br>postoperative). 1 questionnaire is completed for each breast every time. The<br /><br>sample size calculation is based on the patient scar assessment. </p><br>

Secondary Outcome Measures