Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study
LIPOPREP
1 other identifier
interventional
22
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 11, 2022
CompletedStudy Start
First participant enrolled
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedFebruary 2, 2024
February 1, 2024
2.6 years
March 16, 2022
February 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Visual Analogical Pain Scale
6 MONTHS
SF-36 Quality of Life Questionnaire
6MONTHS
Study Arms (2)
adipose graft + Platelet Rich Plasma
EXPERIMENTALadipose graft
OTHERInterventions
intra-articular injection
AT 1 MONTHS BEFORE THE INTERVENTION
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindication to MRI
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiatnce Publique Hopitaux de Marseille
Marseille, Bouche DU Rhone, 13354, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
FRANCOIS CREMIEUX
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2022
First Posted
May 11, 2022
Study Start
September 13, 2022
Primary Completion
May 1, 2025
Study Completion
November 1, 2025
Last Updated
February 2, 2024
Record last verified: 2024-02