Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study
NCT ID: NCT05369273
Last Updated: 2024-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
22 participants
INTERVENTIONAL
2022-09-13
2025-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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adipose graft + Platelet Rich Plasma
intra-articular injection
intra-articular injection
RMI SCANS
AT 1 MONTHS BEFORE THE INTERVENTION
RMI SCANS
AT 1MONTH AFTER THE INTERVENTION
RMI SCAN
AT 6 MONTHS AFTER THE INTERVENTION
adipose graft
intra-articular injection
intra-articular injection
RMI SCANS
AT 1 MONTHS BEFORE THE INTERVENTION
RMI SCANS
AT 1MONTH AFTER THE INTERVENTION
RMI SCAN
AT 6 MONTHS AFTER THE INTERVENTION
Interventions
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intra-articular injection
intra-articular injection
RMI SCANS
AT 1 MONTHS BEFORE THE INTERVENTION
RMI SCANS
AT 1MONTH AFTER THE INTERVENTION
RMI SCAN
AT 6 MONTHS AFTER THE INTERVENTION
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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FRANCOIS CREMIEUX
Role: STUDY_DIRECTOR
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Locations
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Assiatnce Publique Hopitaux de Marseille
Marseille, Bouche DU Rhone, France
Countries
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Central Contacts
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Other Identifiers
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2020-A02972-37
Identifier Type: -
Identifier Source: org_study_id
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