NCT05369273

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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).

Conditions

• Facial Lipofilling

Interventions

Type	Name	Description
OTHER	intra-articular injection	intra-articular injection
RADIATION	RMI SCANS	AT 1 MONTHS BEFORE THE INTERVENTION
OTHER	RMI SCANS	AT 1MONTH AFTER THE INTERVENTION
OTHER	RMI SCAN	AT 6 MONTHS AFTER THE INTERVENTION

Timeline

• Start date: 2022-09-13
• Primary completion: 2025-05-01
• Completion: 2025-11-01
• First posted: 2022-05-11
• Last updated: 2024-02-02

Locations

1 site across 1 country: France