Stromal Vascular Fraction and Platelet-rich Plasma injectable to promote dermal wound healing.

Withdrawn

Conditions: mamma reduction
tissue healing
10040795

Registration Number: NL-OMON45942

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 28

Inclusion Criteria

Females
Age 18-60
BMI equal to or below 30
Patients undergoing a mamma reduction

Exclusion Criteria

Male
Aged below 18 or above 60 years
Aged between 18 and 60 and in the menopause or pre-menopause
BMI above 30
Surgical interventions of the mammae in the year prior to the date of surgery
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, HIV).
Prednisone or other immunotherapy
Smoking
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 POSAS questionnaire<br /><br>containing the patient scar assessment and will focus on: vascularization,<br /><br>pigmentation, thickness, relief, pliability, pain, itchiness, stiffness and<br /><br>irregularity. Questionnaires will be given at predetermined time-points (2<br /><br>weeks, 6 weeks, 12 weeks and 52 weeks postoperative). One questionnaire per<br /><br>patient is completed for each part of the scar of each breast every time. </p><br>

Secondary Outcome Measures