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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: Facial Lipofilling

Treatments: Other: RMI SCAN; Other: intra-articular injection; Other: RMI SCANS

Study type: Interventional

Funder types: Other

Identifiers

NCT05369273

2020-A02972-37

Details and patient eligibility

About

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

Full 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).

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

adipose graft + Platelet Rich Plasma

Experimental group

Treatment:

Other: RMI SCAN

Other: RMI SCANS

Other: intra-articular injection

Other: RMI SCANS

adipose graft

Other group

Treatment:

Other: RMI SCAN

Other: RMI SCANS

Other: intra-articular injection

Other: RMI SCANS