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Stromal Vascular Fraction (SVF) enriched lipofilling plus Platelet Rich Plasma (PRP) for the treatment of the aging face.


- candidate number24087
- NTR NumberNTR5703
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-mrt-2016
- Secondary IDsNL54409.000.15 
- Public TitleStromal Vascular Fraction (SVF) enriched lipofilling plus Platelet Rich Plasma (PRP) for the treatment of the aging face.
- Scientific TitleStromal Vascular Fraction (SVF) enriched lipofilling plus Platelet Rich Plasma (PRP) for the treatment of the aging face.
- ACRONYMPRS (Platelet Rich Stroma) Trial
- hypothesisStromal Vascular Fraction enriched lipofilling in combination with Platelet Rich Plasma (PRP) increases skin quality improvement as compared to lipofilling in combination with PRP alone.
- Healt Condition(s) or Problem(s) studiedAging, Skin complaints
- Inclusion criteria- Females
- Age 35-50
- 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-feb-2016
- planned closingdate16-feb-2019
- Target number of participants64
- InterventionsGroup A: Stromal Vascular Fraction injection, Platelet Rich Plasma injection, lipofilling

Group B: Platelet Rich Plasma injection, lipofilling, 0.9% NaCl injection
- Primary outcomeCutometer and tewameter
- Secondary outcomeVISIA complexion analysis, FACE-Q questionnaire, photographic analysis
- Timepoints6 weeks, 3 months, 6 months and 1 year.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Joris van Dongen
- CONTACT for SCIENTIFIC QUERIES Joris van Dongen
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Bergman Clinics Rijswijk, Arthrex Medizinische Instrumente GmbH
- Publications
- Brief summaryIn 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.
- Main changes (audit trail)4-jun-2016: Inclusion criteria NEW: - Females
- Age 35-60
- Stable normal BMI (20-25) (1 year stable between 20-25)

Exclusion criteria NEW:
- Male
- Aged below 35 or above 50 years
- 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.
- RECORD7-mrt-2016 - 4-jun-2016


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