Danish Title: Afprøvning af indføringsrør Til Forureningsfri Podning af næsens Bihuler (Den Forureningsfri Podepind)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Frequency of staphylococcus aureus positive cultures
研究概览
简要总结
A test of a newly designed device (Contamination free bacterial swab). This device can be used to introduce a standard bacterial swab into the nose without direct or indirect contact with the nasal vestibule.
详细描述
Aim:
The investigators want to improved the current method for bacterial culture test in patients with possible sinusitis by reducing the risk of contamination from the nasal vestibule. The investigators will examine whether significantly fewer Staphylococcus Aureus are detected in the middle meatus when applying a new device for bacterial swab introduction. This device is designed to prevent bacterial pollution from the nasal vestibule.
More precisely, the investigators hope to reduce the frequency of Staphylococcus aureus in nasal swabs from 10-15 % to 0-5 %.
The overall objective is to avoid over-treatment with broad-spectrum antibiotics in patients with sino-nasal disease.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptoms of upper airway disease
排除标准
- •mental illness
- •Need for interpreter
研究组 & 干预措施
Right side
All included participants serve as their own control. A bacterial swab (Eswab 481CE, Copan Diagnostics, Italy), will be introduced to both sides of the nose (to the middle meatus); on the RIGHT side by using the "Contamination free bacterial swab" introduction device.
The "Contamination free bacterial swab" introduction device is a prototype developed for clinical testing.
干预措施: Contamination free bacterial swab (Device)
Left side
All included participants serve as their own control. A bacterial swab (Eswab 481CE, Copan Diagnostics, Italy) will be introduced to both sides of the nose (to the middle meatus); on the LEFT side using the present day clinical procedure (visually guided introduction).
干预措施: Contamination free bacterial swab (Device)
结局指标
主要结局
Frequency of staphylococcus aureus positive cultures
时间窗: 1 year
Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose
次要结局
- Frequency of other bacteria in cultures(1 year)
研究者
Kåre Håkansson
MD, Ph.D
Rigshospitalet, Denmark