Status:
RECRUITING
Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Facial Lipofilling
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective is to show the superiority of the PRP + microfat (MG) mixture compared to microfat alone, in the filling of large subcutaneous depressions of the face and skull. The investigators chose ...
Detailed Description
This clinical superiority study will be conducted in a double-blind, randomized fashion. The follow-up of each patient will be 6 months post injection. 22 patients will be included and randomized int...
Eligibility Criteria
Inclusion
- Men and women of age
- Desiring a procedure with an aesthetic aim
- Having a minimum of 6 months after the neurosurgical procedure for cranial flap replacement
- In the absence of need for neurosurgical revision,
- Informed consent signed by the patient
- Be affiliated with the health insurance
Exclusion
- Contraindication to MRI
- Patients who have already undergone lipofilling at the site of interest before inclusion in the study.
- Contraindication to general anesthesia
- Considered neurosurgical revision
- Carcinological neurosurgery (With the exception of benign tumors with complete excision and/or non-evolving residue requiring no further treatment)
- Healing of the site of interest not acquired at the 1st consultation
- BMI \> 35
- Thrombocytopenia\< 150 G/L
- Thrombocytosis \> 450 G/L
- Known thrombopathy
- HB anemia \< 10g/dl
- Active HIV1 and 2 infections, Agp24, HCV Ac, HbS Ag and AcHbc, HTLV I and II Ac, TPHA
- Chronic treatment with corticoids or NSAIDs or anticoagulant
- Immune deficiency
- Infectious diseases
- Minors
- Pregnant or breastfeeding women
- Patient participating in another clinical trial
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05369273
Start Date
September 13 2022
End Date
November 1 2025
Last Update
February 2 2024
Active Locations (1)
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1
Assiatnce Publique Hopitaux de Marseille
Marseille, Bouche DU Rhone, France, 13354