The Safety and Microbial Changes in the Use of Intranasal Neosporin®: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse events of intranasal Neosporin® in healthy participants.
研究概览
简要总结
Neosporin is an over-the-counter, FDA-approved triple-antibiotic ointment. It is widely used to treat and prevent skin infections following minor burns and injuries. Although the Neosporin® prospect indicates its use is strictly topical, it is often used intranasally by ear, nose, and throat specialists, plastic surgeons, and intensivists to prevent and treat various conditions. Nonetheless, no literature has documented the safety of intranasal Neosporin®. We designed a prospective study to assess the safety of this intervention in healthy participants and to investigate microbial changes before and after the intervention. Healthy participants will apply Neosporin® intranasally for 15 days and record daily adverse events and their severity. Nasal cultures will be drawn before and after the intervention and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years
- •Signed informed consent
- •Healthy volunteers
排除标准
- •Chronic or recurrent nasal conditions
- •Current use of other intranasal medications
- •History of severe allergic reactions to antibiotics
- •History of allergy to the components of Neosporin®
- •Participation in another research protocol
- •Being a staff member or an immediate family member of a staff member
- •Pregnant women
研究组 & 干预措施
Polymyxin B Sulfate 500,000 IU, Bacitracin zinc 40,000 IU, Neomycin Sulfate 0.35g neomycin base
0.5 gr of Polymyxin B Sulfate 500,000 IU, Bacitracin zinc 40,000 IU, Neomycin Sulfate 0.35g neomycin base will be applied intranasally in healthy participants for 15 days
干预措施: Intranasal application of Polymyxin B Sulfate 500,000 IU, Bacitracin zinc 40,000 IU, Neomycin Sulfate 0.35g neomycin base (Drug)
结局指标
主要结局
Adverse events of intranasal Neosporin® in healthy participants.
时间窗: 16 days
次要结局
未报告次要终点
研究者
Dr. Adrian Camacho-Ortiz
Head of Department
Hospital Universitario Dr. Jose E. Gonzalez