| Registry | NCT05369273, acronym LIPOPREP |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 22 (Estimated) |
| Sponsor | Assistance Publique Hopitaux De Marseille (Other) |
| Conditions | Facial Lipofilling |
| Interventions | intra-articular injection, RMI SCANS, RMI SCAN (Other, radiation) |
| Dates | start 2022-09-13, primary completion 2025-05-01 (estimated), completion 2025-11-01 (estimated), first posted 2022-05-11, last updated 2024-02-02 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Facial Lipofilling All trials of intra-articular injection All trials of RMI SCANS
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
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| adipose graft + Platelet Rich Plasma | Experimental | Other: intra-articular injection; Radiation: RMI SCANS; Other: RMI SCANS; Other: RMI SCAN | |
| adipose graft | Other | Other: intra-articular injection; Radiation: RMI SCANS; Other: RMI SCANS; Other: RMI SCAN |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Assiatnce Publique Hopitaux de Marseille | Marseille, Bouche DU Rhone | France | Recruiting |