Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study

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Description

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 to study the post neurosurgical sequelae after removal and reinstallation of the cranial flap, with, for example, damage to the temporal muscle and asymmetry of the temples or sinking of the cranial flap

Targeted Conditions

Study Overview

Start Date
September 13, 2022
Completion Date
November 1, 2025
Enrollment
22
Date Posted
May 11, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Assiatnce Publique Hopitaux de Marseille
Marseille, Bouche DU Rhone 13354, France

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

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 Criteria:

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

Study Contact Info

Study Contact Name
Baptiste BERTRAND; ALEXANDRA GIULIANI
Study Contact Phone

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Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study 0 reviews

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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 into 2 arms: PRP + microfat or microfat alone. The primary endpoint will be assessed by a radiologist in a blinded fashion, using 3 MRI scans: the month before the procedure, the day after, and at 6 months (time at which fat resorption decreases).
NCTid (if applicable)
NCT05369273