Clinical Trial: Clinical Survey of Different Abutment Topologies
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems
Brief Summary: 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.
Detailed Summary:
Sponsor: Oticon Medical
Current Primary Outcome: Number of colony forming units (CFU) [ Time Frame: 3 months post-surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 [ 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 ]
Original Secondary Outcome: Same as current
Information By: Oticon Medical
Dates:
Date Received: November 14, 2014
Date Started: October 2014
Date Completion: December 2017
Last Updated: April 7, 2017
Last Verified: April 2017