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

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

Study Overview

• Status: Recruiting
• Conditions: Facial Lipofilling
• Intervention / Treatment: Other: intra-articular injection; Radiation: RMI SCANS; Other: RMI SCANS; Other: RMI SCAN

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 Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Baptiste BERTRAND; Phone Number: 0491435303; Email: baptiste.bertrand@ap-hm.fr
• Study Contact Backup: Name: ALEXANDRA GIULIANI; Phone Number: +33 0491382747; Email: alexandra.giuliani@ap-hm.fr

Study Locations

• France
  • Bouche DU Rhone
    • Marseille, Bouche DU Rhone, France, 13354
      • Recruiting
      • Assiatnce Publique Hopitaux de Marseille
      • Principal Investigator: BAPTISTE BERTRAND

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François CREMIEUX, Assistance Publique Hôpitaux Marseille

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A02972-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No