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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Facial Lipofilling

Intervention / Treatment
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* Other: intra-articular injection
* Radiation: RMI SCANS
* Other: RMI SCANS
* Other: RMI SCAN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women of age Desiring a procedure with an aesthetic aim Having a minimum of 18 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adipose graft + Platelet Rich Plasma<br> | Other: intra-articular injection<br>* intra-articular injection<br>Radiation: RMI SCANS<br>* AT 1 MONTHS BEFORE THE INTERVENTION<br>Other: RMI SCANS<br>* AT 1MONTH AFTER THE INTERVENTION<br>Other: RMI SCAN<br>* AT 6 MONTHS AFTER THE INTERVENTION<br>|
| Other: adipose graft<br> | Other: intra-articular injection<br>* intra-articular injection<br>Radiation: RMI SCANS<br>* AT 1 MONTHS BEFORE THE INTERVENTION<br>Other: RMI SCANS<br>* AT 1MONTH AFTER THE INTERVENTION<br>Other: RMI SCAN<br>* AT 6 MONTHS AFTER THE INTERVENTION<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resorption 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 6MONTHS |