Status:
COMPLETED
The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer
Lead Sponsor:
Bergman Clinics
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Lipofilling
Human Autologous Fat Transfer
Eligibility:
FEMALE
30-65 years
Phase:
PHASE2
PHASE3
Brief Summary
In this prospective, randomized clinical trial, lipofilling of the midface with Platelet Rich Plasma (PRP) is compared with lipofilling of the midface without PRP. The main objective of this study is ...
Detailed Description
Soft tissue augmentation by the means of lipofilling is nowadays a frequently used technique in all forms of plastic surgery. In aesthetic facial surgery it has shown to increase the rejuvenating effe...
Eligibility Criteria
Inclusion
- Females
- Aged 30-65
- Stable normal BMI (20-25) (1 year stable between 20-25)
Exclusion
- •• Male
- Aged below 30 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
- 20\<BMI\<25 or an unstable BMI: 1 year plus-minus 5 points.
- Pregnancy or active child wish
- Frequent exposure to known carcinogenic substances ( eg. work related).
- Active or previous use of hormone replacement therapy.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01461785
Start Date
April 1 2012
End Date
January 1 2015
Last Update
October 17 2017
Active Locations (1)
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1
Bergman Clinics
The Hague, South Holland, Netherlands, 2516 BA