No registrations found.
ID
Source
Brief title
Health condition
Ageing of the face, skin quality improvement.
Veroudering van het gelaat, huidkwaliteit verbetering.
Sponsors and support
Arthrex Germany
Intervention
Outcome measures
Primary outcome
Cutometer and tewameter
Secondary outcome
VISIA complexion analysis, FACE-Q questionnaire, photographic analysis
Background summary
In this prospective study we investigate the potential beneficial effect of adding a Stromal Vascular
Fraction (SVF) to Platelet Rich Plasma (PRP) + lipofilling. Amelioration of skin quality improvement of
the aging face is anticipated. One group will receive lipofilling + PRP + SVF and the other group will
receive lipofiling + PRP + 0,9% NaCl solution. SVF will be created by using a mechanical dissociation
procedure named: the FAT (Fractionation of Adipose Tissue) procedure. Postoperative skin quality
measured with a Multi Probe Adapter system (Courage Khanza Colone Germany) containing two skin
measurement probes (Cutometer MPA580: Mechanical parameters of the skin and Tewameter
TM300:Skin barrier function and transepidermal water loss,) on predetermined fixed positions in the
face. Postoperative improvement is analyzed by a photographic panel assessment as well. Panel
evaluation will focus on volume restoration and remaining volume over time. Postoperative skin
parameters are measured in a predetermined fixed mask in the face, with a VISIA® Complexion
Analysis (Canfield Scientific Inc.) containing several parameters: skin texture, wrinkle depth, porien
and brown and red spots. Standardized FACE-Q questionnaires will focus on satisfaction after the
treatment, social wellbeing and recovery. All measurements will be done on predetermined time-
points: preoperative, 6 weeks, 3 months, 6 months, 12 months postoperative.
Study objective
Stromal Vascular Fraction enriched lipofilling in combination with Platelet Rich Plasma (PRP) increases skin quality improvement as compared to lipofilling in combination with PRP alone.
Study design
6 weeks, 3 months, 6 months and 1 year.
Intervention
Group A: Stromal Vascular Fraction injection, Platelet Rich Plasma injection, lipofilling
Group B: Platelet Rich Plasma injection, lipofilling, 0.9% NaCl injection
Joris van Dongen
Boterdiep 94 kamer 23
Groningen 9712 LS
The Netherlands
+31619594029
jorisavandongen@gmail.com
Joris van Dongen
Boterdiep 94 kamer 23
Groningen 9712 LS
The Netherlands
+31619594029
jorisavandongen@gmail.com
Inclusion criteria
- Females
- Age 35-60
- Stable normal BMI (20-25) (1 year stable between 20-25)
Exclusion criteria
- Male
- Aged below 35 or above 50 years
- Aged between 35 and 50 and in the menopause or pre-menopause
- Surgical interventions of the face 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).
- Smoking
- 20>BMI>25 or an unstable BMI: 1 year ± 5 points.
- Pregnancy or active child wish
- Frequent exposure to known carcinogenic substances (e.g. work related).
- Active or previous use of hormone replacement therapy.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5597 |
| NTR-old | NTR5703 |
| CCMO | NL54409.000.15 |
| OMON | NL-OMON46886 |