Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- resorption rate of the injected fat
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Pregnant or breastfeeding women
- •Patient participating in another clinical trial
结局指标
主要结局
resorption rate of the injected fat
时间窗: 6 months
calculated from volumetric measurements assessed from MRI 2 (post-injection) and MRI3 (at 6 months): V MRI 2 - V MRI3
次要结局
- Visual Analogical Pain Scale(6 MONTHS)
- SF-36 Quality of Life Questionnaire(6MONTHS)