NCT03656588Unknown不适用
Does the Addition of Hydrogen Peroxide to Chlorhexidine Preoperative Skin Preparation Reduce the Rate of Propionibacterium Acnes Positive Culture in the Shoulder
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- colonization of p.acnes in the dermis of the shoulder
研究概览
简要总结
This is a prospective, randomized controlled trial to evaluate the ability of hydrogen peroxide preparation in addition to chlorhexidine to decrease the colonization of Propionibacterium acnes(a bacteria commonly found in the dermis of the skin surrounding the shoulder in order to decrease postoperative joint infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All male patients (>18) undergoing shoulder arthroscopy
排除标准
- •Female patients
- •Patients with active acne
- •Patients who have taken antibiotics within a month of their surgery
- •Subjects allergic to any of the following agents:
- •o Benzoyl peroxide
- •Subjects with psoriatic/eczematous lesions on the shoulder girdle.
研究组 & 干预措施
a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by
Active Comparator
干预措施: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol (Drug)
b. Iodine scrub and ChloraPrep alone
Active Comparator
干预措施: Iodine scrub and ChloraPrep alone (Drug)
结局指标
主要结局
colonization of p.acnes in the dermis of the shoulder
时间窗: 14 days in culture
number of colony forming units grown in bacterial culture
次要结局
未报告次要终点
研究者
研究点 (1)
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