Facial Lipofilling
Conditions
Brief 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).
Interventions
intra-articular injection
RADIATIONRMI SCANS
AT 1 MONTHS BEFORE THE INTERVENTION
OTHERRMI SCAN
AT 6 MONTHS AFTER THE INTERVENTION
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| resorption rate of the injected fat | 6 months | calculated from volumetric measurements assessed from MRI 2 (post-injection) and MRI3 (at 6 months): V MRI 2 - V MRI3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogical Pain Scale | 6 MONTHS | 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. |
| SF-36 Quality of Life Questionnaire | 6MONTHS | 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 |
Countries
France
Contacts
Primary ContactBaptiste BERTRAND
Backup ContactALEXANDRA GIULIANI
Outcome results
None listed