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 ]

The primary end point is CFU counts 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