Prevalence of Mucosal Biofilm Formations in Adenoidectomy Specimens
Condition: Chronic Serous Otitis Media, Simple or Unspecified
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): With chronic middle ear effusion; Without chronic middle ear effusion
Intervention type(s): Procedure; Procedure
Intervention description(s): Children with chronic middle ear effusion having adenoidectomy.; Children without chronic middle ear effusion as a control group having adenoids removed for chronic obstruction.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Serous otitis media; Biofilm; Adenoidectomy; Chronic otitis media