跳至主要内容
临床试验/NCT01022944
NCT01022944已完成不适用

Prevalence of Mucosal Biofilm Formations in Adenoidectomy Specimens. A Case Control Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
1
主要终点
Prevalence of mucosal biofilm formations in adenoidectomy specimens analyzed using Confocal Laser Scanning Microscopy with double staining

研究概览

简要总结

Rationale: Bacterial biofilms are defined as an assemblage of bacterial cells enclosed in a self-produced glycocalyx matrix. Adherence on surfaces, and resistance to both antibiotic treatments and host defenses are ones of the major clinical features of bacterial biofilms. Hence, biofilm formations represent a serious clinical problem: they persist in human tissues and play a role in a large number of chronic and resistant infections. It has been estimated that more than 65% of all human bacterial infections involve biofilms. Recently, the investigators have demonstrated the presence of mucosal bacterial biofilms in adenoid tissues removed during routine adenoidectomy. Bacterial biofilms were visualized using Confocal Laser Scanning Microscopy (CLSM) with a technique of double staining showing both the bacterial cells and the glycocalyx matrix. Although this study clearly established that adenoids tissues can harbour mucosal biofilms, the prevalence of 54% the investigators found suggested that some groups of children may contain more biofilm formations than others. In an effort to relate the findings of mucosal biofilm with the clinical presentation, the investigators have designed the present work to compare the prevalence of mucosal biofilms in adenoidectomy specimens in two groups: one group of children with chronic otitis media (COM) with effusion versus another group of children without any COM, having adenoids removed for chronic obstruction.

详细描述

The aim of this case-control study is to compare the prevalence of biofilms formations in adenoid tissues of children with COM versus a control group without any COM.

Design: This is a monocentric, prospective, unrandomized case-control study comparing the prevalence of biofilm formations in adenoid tissues of two groups.

Clinical research study without direct medical benefit: during routine adenoidectomy, specimens are not used and thrown away. This study do not modify the common management of included children.

Number of subjects required: A considered approach of simple size calculation have been made using a method proposed by MIETINEN for Mc NEMAR Chi2 test. Simple size N=104 will allow 80% power to detect different of 20% (absolute), considering a total percentage of discordance pair at 30 %.

Expected results: a higher prevalence (30% estimation) of biofilm formations in group 1 in comparison with that in group 2 would be the first clinical research study bringing understanding of the role of adenoid tissues by harboring mucosal biofilms in otitis prone children.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Months 至 10 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Group 1 and 2
  • •obtained informed consent by both parents and child (if possible),
  • •age > 18 months and <10 years
  • •chronic serous otitis media lasting more than 3 months (group 1).
  • •Group 1 only:
  • •chronic secretory otitis media
  • •Group 2 only:
  • •hypertrophia adenoid vegetations without sinusal oropharyngeal infections

排除标准

  • •No informed consent
  • •age < 18 months or > 10 years
  • •Eustachian tube dysfunction
  • •Immunodeficiency

研究组 & 干预措施

Group 2 :

Other

Children without chronic middle ear effusion as a control group having adenoids removed for chronic obstruction.

干预措施: Without chronic middle ear effusion (Procedure)

Group 1

Other

Children with chronic middle ear effusion having adenoidectomy.

干预措施: With chronic middle ear effusion (Procedure)

结局指标

主要结局

Prevalence of mucosal biofilm formations in adenoidectomy specimens analyzed using Confocal Laser Scanning Microscopy with double staining

时间窗: at 2 years

次要结局

  • To build up a tissue bank of human tissue from adenoids and the middle ear for further bacterial identification(during the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验