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Clinical Trial 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 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


Clinical Trial 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). ;


Study Design


NCT number NCT05369273
Study type Interventional
Source Assistance Publique Hopitaux De Marseille
Contact Baptiste BERTRAND
Phone 0491435303
Email baptiste.bertrand@ap-hm.fr
Status Recruiting
Phase N/A
Start date September 13, 2022
Completion date November 2025