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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
intra-articular injection
AT 1 MONTHS BEFORE THE INTERVENTION
AT 1MONTH AFTER THE INTERVENTION
AT 6 MONTHS AFTER THE INTERVENTION
Assiatnce Publique Hopitaux de Marseille
Marseille, Bouche DU Rhone, France
RECRUITINGresorption rate of the injected fat
calculated from volumetric measurements assessed from MRI 2 (post-injection) and MRI3 (at 6 months): V MRI 2 - V MRI3
Time frame: 6 months
Visual Analogical Pain Scale
The measurement of the impact of pain on the cranial scar will be evaluated using a visual analog scale (VAS), rated from 0 to 100.
Time frame: 6 MONTHS
SF-36 Quality of Life Questionnaire
The Short Form (36) Health Survey is a standardized test for measuring quality of life. It is a measure of health status. A score for each dimension of the SF-36 was calculated, ranging from 0 to 100
Time frame: 6MONTHS
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