Using Platelet Rich Plasma with Microfat for Treating Cranial Flap Scars
Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study
This study is testing if combining Platelet Rich Plasma with microfat injections can make scars from cranial flap surgeries look better for people who have these types of scars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, Bouche DU Rhone) |
| Trial ID | NCT05369273 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of combining Platelet Rich Plasma (PRP) with microfat injections to improve the appearance of large subcutaneous depressions resulting from cranial flap surgeries. Conducted in a double-blind, randomized manner, the study will include 22 participants who will be assigned to receive either the PRP + microfat mixture or microfat alone. The primary outcome will be assessed through MRI scans taken before the procedure, immediately after, and at six months post-injection to measure fat resorption and aesthetic improvement.
Who should consider this trial
Good fit: Ideal candidates are adults who have undergone neurosurgical procedures involving cranial flap replacement and are seeking aesthetic improvement at least six months post-surgery.
Not a fit: Patients with contraindications to MRI, previous lipofilling at the site, or those requiring neurosurgical revision may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the aesthetic outcomes for patients with cranial flap scars, leading to improved quality of life.
How similar studies have performed: While the combination of PRP and microfat is a relatively novel approach, similar studies have shown promising results in enhancing tissue regeneration and aesthetic outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Marseille, Bouche DU Rhone
- Assiatnce Publique Hopitaux de Marseille — Marseille, Bouche DU Rhone, France (Recruiting)
Study contacts
- Study coordinator: Baptiste BERTRAND
- Email: baptiste.bertrand@ap-hm.fr
- Phone: 0491435303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.