The use of activated Platelet Rich Plasma (PRP) in human autologous fat transfer.

Completed

Conditions: atrophy
dermal improvement.
loss of volume
10040795

Registration Number: NL-OMON39492

Lead Sponsor: Bergman Clinics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

* Females
* Aged 45-65
* Stable normal BMI (20-25) (1 year stable between 20-25)

Exclusion Criteria

* Male
* Aged below 45 or above 65 years
* Aged between 45 and 55 and in the menopause
* Aged between 55 and 65 and pre-menopause
* Prior operations in the mid-face
* Any oncological event in the patients history
* A known psychiatric condition
* A known systemic disease that will impair wound healing ( eg diabetus mellitus, known atherosclerosis with an event that required hospitalization, collagen diseases, diseases of the skin).
* Smoking
* BMI <20 or >25 or an unstable BMI: 1 year ± 5 points.
- Pregnancy or active child wish
- Frequent exposure to known carcinogenic substances ( eg. 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 skin quality measured with a Multi Probe Adapter system (Courage<br /><br>Khanza Colone Germany) containing several skin measurement probes (Maxameter<br /><br>mx18: Assessing melanin content and erythema level, Tewameter TM300: Skin<br /><br>barrier function and transepidermal waterloss, Cutometer MPA580: Mechanical<br /><br>parameters of the skin) on predetermined fixed positions in the face on<br /><br>predetermined times .</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Scores derived from standardized photographic assessment by two panels (<br /><br>plastic surgeons and layperons). The method used for assessment is based on<br /><br>methods described by Moolenburg and Strasser. Output parameter is a visual<br /><br>analogue score ranging from 0 (very poor<br /><br>facial volume) to 10 ( excellent facial volume), and for skin quality 0 ( pour<br /><br>skin quality) to 10 ( excellent skin quality). Standardized photos will be<br /><br>taken at the follow-up visits.<br /><br>Results of the patient questionnaire with endpoints: number of complications,<br /><br>Return to work/Return to social activities without masking in days. Patient<br /><br>evaluation of their own appearance using a visual analogue scale ranging from 0<br /><br>(very dissatisfied) to 10 (most satisfied). </p><br>