"BP as a Super-light Mesh and as a New Fixing Device for General, Emergency and Prosthetic Surgery. The BP Implantation Effects on Immunity System, on the Metabolism and on Sealing. Preliminary Experimentation of Small Feasibility Study"
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- bio-compatibility by liver performance (by SGOT(Serum Glutamic Oxaloacetic Transaminase)
研究概览
简要总结
The Buckypaper (BP) is an innovative material that has attracted the attention of many research groups engaged in the study of its possible applications in various technological fields. Our purpose is demonstrate the viability of the application of nanotechnologies to the General Surgery in human with thwe use of a new self standing prosthetic device for the reconstruction of abdominal wall defects.
详细描述
The interesting material properties, such as good mechanical strength, electrical conductivity, low density, porosity adaptable, are closely associated to the intrinsic characteristics of carbon nanotubes (CNTs), of which BP is made . The high surface development of CNT, in addition to promoting their aggregation, allows the preparation of micro-and nano-porous membranes that exclude the passage of colloidal particles with a diameter greater than 50 nm. The micro-porous structure, also gives the BP high capacity to absorb liquids, such as water, for which the effect of capillarity, penetrates quickly in the mesh material. This could be a possible interpretation of the rapid and effective adhesion of BP to humid biological tissues observed in our preliminary studies on the effects of the BP implanted in vivo.
The bio-adhesion of BP has been documented in ex vivo preliminary experiments mechanical peeling (bench surgery). The results showed that the force required the posting of BP from organic support is much greater than that required for the conventional prosthesis made from polymer networks, commonly used in human hernia surgery fixed with fibrin glue or synthetic materials. Based on these assessments the use of BP could be introduced in the field of prosthetic surgery.
Based on these assessments and based on the potential offered by the use of BP in the field of prosthetic surgery, deductible by the intrinsic characteristics of the material in this project is expected to further research for the development of a new generation of prosthetic materials for humans use, easily implantable by the surgeon without the need for sutures, graphs and / or biological glues.
The reasons are:
- stitches: they could tighten the knot vessels (ischemia-atrophy) or nerves (chronic pain);
- graphs: placing blind and can cause bleeding or pain;
- biological glues: derived from the plasma of donors and thus could transmit diseases unknown.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 4 Months（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female Sprague Dawley rats of 300-500 grams of body weight
排除标准
- •any kind of illness in rat subjects
- •out breed animals
结局指标
主要结局
bio-compatibility by liver performance (by SGOT(Serum Glutamic Oxaloacetic Transaminase)
时间窗: 5 weeks
bio-compatibility of Buckypaper implanted in a lumbar scar by evaluation of liver function by SGOT(Serum Glutamic Oxaloacetic Transaminase), SGPT(Serum Glutamic PyruvateTransaminase), GGT(gamma glutamyl transferase), ALP(alkaline phosphatase) and fractionated bilirubin, PT(Prothrombin Time), APTT/PTT(Activated partial thromboplastin time), Fibrinogen. The evaluation will be performed at the beginning of experimentation and at the sacrifice after 35 days and will be evaluated the difference (delta) before and after implantation of BP
次要结局
- cancer cell viability if exposed to BP(5 weeks)
- bio-compatibility by kidney performance (by BUN and blood creatinine, and creatinine clearance)(5 weeks)
- bio-compatibility by marrow biologic performance (by CBC(Complete Blood Count)(5 weeks)
研究者
Massimo Chiaretti
Dr, PhD, MSc
University of Roma La Sapienza