This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Department of Otorhinolaryngology, Karolinska University Hospital
Stockholm, Sweden
Number of colony forming units (CFU)
The primary end point is CFU counts 3 months post-surgery.
Time frame: 3 months post-surgery
Number of colony forming units (CFU) on abutment (CFU/abutment)
Time frame: 3 months post-surgery
Number of colony forming units (CFU) on abutment (CFU/abutment)
Time frame: 12 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
Time frame: 3 months post-surgery
Number of colony forming units (CFU), strip (CFU/strip)
Time frame: 12 months post-surgery
Number of colony forming units (CFU) in tissue samples (CFU/mg
Time frame: 3 months post-surgery
Number of colony forming units (CFU) in tissue samples (CFU/mg
Time frame: 12 months post-surgery
RNA level for host inflammatory response
Time frame: 3 months post-surgery
RNA level for tissue repair
Time frame: 3 months post-surgery
RNA level for host host microbial infection response
Time frame: 3 months post-surgery
RNA level for host inflammatory response
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Time frame: 12 months post-surgery
RNA level for tissue repair
Time frame: 12 months post-surgery
RNA level for host host microbial infection response
Time frame: 12 months post-surgery
Histology investigation of tissue biopsy
Time frame: 3 months post-surgery
Histology investigation of tissue biopsy
Time frame: 12 months post-surgery