跳至主要内容
临床试验/NCT02328352
NCT02328352Unknown1 期

The Buckypaper as a New Device in the Treatment of Some Solid Cancer and Hematopoietic System Tumors and as a New Fixing Device for Prosthetic Surgery. In Vivo Study on Effects of BP Implantation, Preliminary to Human Surgical Applications

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
30
试验地点
2
主要终点
number of moths without surgical hernia recurrence

研究概览

简要总结

Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias in humans, in laparotomic procedures and as a new device for the treatment of solid cancer and hematopoietic system tumors.

The experimentation on this new material, preliminary conducted on breed female rabbit New Zeeland, will be applicable to human, if the results in terms of toxicity and durability will be comfortable.

详细描述

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 preliminary to human experimentation. In fact the experimentation, preliminary conducted on animal model, will be applicable to human, if the results in terms of toxicity and durability will be comfortable.

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 microporous 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 biological tissues observed in our studies on the effects of the material implanted in vivo. The bioadhesion of BP has been documented in ex vivo experiments mechanical peeling (bench surgery), conducted in advance using as substrate, guinea pig, rats, the abdominal muscle fascia of rabbits. 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 hernia surgery fixed with glue and biological prosthetic material bioadhesive synthetic currently marketed . 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 use surgical -based BP, easily implantable by the surgeon without the need for sutures, graphs and / or biological glues . The reasons are:

  1. stitches: they could tighten the knot vessels (ischemia-atrophy) or nerves (chronic pain);
  2. graphs: placing blind and can cause bleeding or pain;
  3. biological glues: derived from the plasma of donors and thus could transmit diseases unknown.

It is still unknown if BP has the appropriate mechanical properties to withstand the stresses that occur on the abdominal wall and In any case is documented the good bio-adhesion on living tissues and anatomical preparations, but only if made humid.

For this reason it was decided to prepare composite materials BP/polypropylene. Such materials, defined as "coupled", will be obtained by adhering on the smooth face of BP, a polymeric support which confers to the hybrid film, the correct mechanical resistance. Such a system may be subject to further changes. Indeed, exploiting the functional groups present or introduced into the crystalline structure of MWCNTs and/or on the polymer, it will be possible to implant on the muscle/muscular fascia surface, the composite material, to obtain gripping. Moreover, biologically active molecules, with functions antimicrobial, anti-adhesive, anti-inflammatory or analgesic, can be introduced into the crystalline structure of MWCNTs, for modulate the inflammatory response and the incorporation of the implanted material in the fibrous scar.

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
3 Months 至 6 Months(Child)
性别
Female
接受健康志愿者

入选标准

  • animal model: New Zeeland female rabbits of 3000 gr of body weight -

排除标准

  • any kind of illness in rabbit subjects

结局指标

主要结局

number of moths without surgical hernia recurrence

时间窗: 54 weeks

Durability (in months) without recurrence of hernia and incisional hernia of surgical device.

次要结局

  • number of mm displacement from the point of implantation (at 12 weeks after BP implantation)(3 months)
  • number of BP fragments in bioptic samples of Bowman capsule(12 weeks)
  • number of viable tumor cells in cultures after 48 hours of exposition to BP(48 hours)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Chiaretti

Dr

University of Roma La Sapienza

研究点 (2)

Loading locations...

相似试验