NCT02304692已完成不适用
C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Number of colony forming units (CFU)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult (18 years of age or older) patient eligible for a bone anchored hearing system
排除标准
- •Inability or unwillingness to participate in follow-up
- •Skin thickness of > 10 mm
- •Diseases known to compromise bone quality
- •Irradiated in the implant area
结局指标
主要结局
Number of colony forming units (CFU)
时间窗: 3 months post-surgery
The primary end point is CFU counts 3 months post-surgery.
次要结局
- Number of colony forming units (CFU) on abutment (CFU/abutment)(12 months post-surgery)
- Number of colony forming units (CFU), strip (CFU/strip)(12 months post-surgery)
- Number of colony forming units (CFU) in tissue samples (CFU/mg(12 months post-surgery)
- RNA level for host inflammatory response(12 months post-surgery)
- RNA level for tissue repair(12 months post-surgery)
- RNA level for host host microbial infection response(12 months post-surgery)
- Histology investigation of tissue biopsy(12 months post-surgery)
研究者
研究点 (2)
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