Clinical trial NCT05369273: Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study
Official title: Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Facial Lipofilling
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: resorption rate of the injected fat
timeFrame: 6 months
Secondary outcomes:
measure: Visual Analogical Pain Scale
timeFrame: 6 MONTHS
measure: SF-36 Quality of Life Questionnaire
timeFrame: 6MONTHS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assiatnce Publique Hopitaux de Marseille
state: Bouche DU Rhone
Study officials:
affiliation: ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
name: FRANCOIS CREMIEUX
role: STUDY_DIRECTOR
References: