临床试验/NCT01007240

NCT01007240Unknown1 期

Clinical Study of the Antibacterial Properties of the Nano Particles Which Incorporated With the Soft Liner Silicone - in Obturators

Hadassah Medical Organization0 个研究点目标入组 10 人开始时间: 2010年1月1日最近更新: 2009年11月4日

适应症

干预措施

试验速览

阶段: 1 期
发起方: Hadassah Medical Organization
入组人数: 10
主要终点: bacterial growth

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The aim of this study is to evaluate the antibacterial activity of crosslinked quaternary ammonium polyethylenimine (PEI) nanoparticles incorporated at 1-2% w/w in a commercial soft liner material when compared to the commercial soft liner material.

The investigators' results in vitro showed a significant delay in bacterial growth.

Therefore, the investigators assume to have the same delay in vivo- on patients.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Prevention
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•patients post maxillectomy, who are using obturators

排除标准

•patients who are not using obturators

研究组 & 干预措施

soft liner with nano particles

Experimental

the obturators of this patients will be relined with soft liner, with incorporated nano particles. after a week, the soft liner will be taken off, and will be checked for bacterial adhesion.

干预措施: polyethylenimine (PEI) nanoparticles. (Device)

结局指标

主要结局

bacterial growth

时间窗: a week

次要结局

未报告次要终点

研究者

发起方

Hadassah Medical Organization

申办方类型

Other

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