Addition of Platelet Rich Plasma (PRP) in Microfat Lipofi... | NCT05369273

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2022Actual

Primary Completion Date

May 2025Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Mar 16, 2022

First Submission Date that Met QC Criteria

May 10, 2022

First Posted Date

May 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2024

Last Update Posted Date

Feb 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
adipose graft + Platelet Rich Plasma	Experimental		Other: intra-articular injection Radiation: RMI SCANS Other: RMI SCANS Other: RMI SCAN
adipose graft	Other		Other: intra-articular injection Radiation: RMI SCANS Other: RMI SCANS Other: RMI SCAN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intra-articular injection	Other	intra-articular injection	adipose graft adipose graft + Platelet Rich Plasma

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Baptiste BERTRAND	Contact	0491435303		baptiste.bertrand@ap-hm.fr
ALEXANDRA GIULIANI	Contact	0491382747	+33	alexandra.giuliani@ap-hm.fr

Overall Officials

Name	Affiliation	Role
FRANCOIS CREMIEUX	ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiatnce Publique Hopitaux de Marseille	Recruiting	Marseille	Bouche DU Rhone	13354	France

ID	Term
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics