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

Not Applicable

Recruiting

• Conditions: Facial Lipofilling
• Interventions: Other: intra-articular injection; Other: RMI SCANS; Other: RMI SCAN

• Registration Number: NCT05369273
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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).

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-11
• Study Start: 2022-09-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adipose graft	intra-articular injection	-
adipose graft + Platelet Rich Plasma	intra-articular injection	-
adipose graft	RMI SCAN	-
adipose graft + Platelet Rich Plasma	RMI SCAN	-
adipose graft	RMI SCANS	-
adipose graft + Platelet Rich Plasma	RMI SCANS	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Assiatnce Publique Hopitaux de Marseille; 🇫🇷 Marseille, Bouche DU Rhone, France