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临床试验/NCT01461785
NCT01461785已完成2 期

The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer

Bergman Clinics1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Cutometry

研究概览

简要总结

In this prospective, randomized clinical trial, lipofilling of the midface with Platelet Rich Plasma (PRP) is compared with lipofilling of the midface without PRP. The main objective of this study is to investigate the effect of the addition of PRP to the autologous fat transfer on local skin quality improvement, graft survival, and recovery after the procedure.

详细描述

Soft tissue augmentation by the means of lipofilling is nowadays a frequently used technique in all forms of plastic surgery. In aesthetic facial surgery it has shown to increase the rejuvenating effect, in reconstructive surgery it has earned its place in the correction of soft tissue defects and athropy.

Post-operative loss of volume of the transplanted fat remains an uncertain factor in the procedure. In current literature, there are three main hypotheses on etiology of postoperative decrease in the graft volume; 1: the viability of the injected fat cells 2: impaired graft revascularization at the target site 3: the degree of fibrosis in the target area. Mentioned factors have limited the application of (large) volume lipotransfer.

Positive effects of lipofilling on skin quality have been reported. Coleman observed softening of wrinkles, decreasing pore size and pigmentation improvements on graft sites. Possible mechanisms of the claimed regenerative properties of the lipograft are explained by the high number of adipose derived stem cells. Although frequently described in literature, no objective results have been published to this date.

In this prospective study the investigators examine new methods in preventing postoperative volume loss by the addition of Platelet Rich Plasma (PRP), derived from the patients own blood, to the injected fat graft. The added PRP contains a wide range of growth factors for instance: Epidermal growth factor (EGF), Platelet derived growth factor (PDGF-AA), Transforming growth factor (TGF-B1, TGF-B2), Fibroblast growth factor (FGF) and Vascular endothelial growth factor (VEGF).

All previously mentioned factors have shown to play a key role in tissue regeneration after tissue damage. Especially VEGF is of great interest with the ability to promote neo-angiogenesis in the graft, and thus, in theory, reducing fat necrosis and seroma formation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Aged 30-65
  • •Stable normal BMI (20-25) (1 year stable between 20-25)

排除标准

  • •Aged below 30 or above 65 years
  • •Aged between 45 and 55 and in the menopause
  • •Aged between 55 and 65 and pre-menopause
  • •Prior operations in the mid-face
  • •Any oncological event in the patients history
  • •A known psychiatric condition
  • •A known systemic disease that will impair wound healing ( eg diabetus mellitus, known atherosclerosis with an event that required hospitalization, collagen diseases, diseases of the skin).
  • •20<BMI<25 or an unstable BMI: 1 year plus-minus 5 points.
  • •Pregnancy or active child wish
  • •Frequent exposure to known carcinogenic substances ( eg. work related).
  • •Active or previous use of hormone replacement therapy.

研究组 & 干预措施

GROUP A: PRP +

Experimental

Group A (16 subjects) will receive lipofilling enriched with 3 ml of autologous PRP ( Platelet rich plasma) with lipofilling

干预措施: Addition of PRP ( platelet rich plasma) to the lipograft (Biological)

GROUP A: PRP +

Experimental

Group A (16 subjects) will receive lipofilling enriched with 3 ml of autologous PRP ( Platelet rich plasma) with lipofilling

干预措施: Lipofilling of the midface (Procedure)

GROUP B: PRP -

Placebo Comparator

Group B ( 16 subjects) will receive lipofilling without addition PRP. 27 ml blood will be drawn from the patient, but will be discarded, and not turned into PRP.

干预措施: Lipofilling of the midface (Procedure)

结局指标

主要结局

Cutometry

时间窗: 1 year post-operative of the last included patient, estimate is 18 months

Postoperative skin quality measured with a Multi Probe Adapter system (Courage Khanza Colone Germany) containing several skin measurement probes (Maxameter mx18: Assessing melanin content and erythema level, Tewameter TM300: Skin barrier function and transepidermal waterloss, Cutometer MPA580: Mechanical parameters of the skin) on predetermined fixed positions in the face on predetermined times . (pre-operative, 1 week postoperative, 3 months post-operative and 1 year post-operative.)

次要结局

  • Panel assessment(1 year post-operative of the last included patient, estimate is 18 months)
  • Patient questionnaire(1 year post-operative of the last included patient, estimate is 18 months)

研究者

发起方
Bergman Clinics
申办方类型
Other
责任方
Principal Investigator
主要研究者

JCN Willemsen, MD, PhD candidate

Principal investigator of clinical research

Bergman Clinics

研究点 (1)

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