A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations
试验速览
- 阶段
- 3 期
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Skin infection
研究概览
简要总结
Alcohol is used to disinfect the skin prior to injections in order to prevent infections caused by bacteria on the skin being injected within tissue. At present, however, clinical trials do not demonstrate a clinical impact of using or not using alcohol swabs on infections and infection symptoms calling into question the practice of using it prior to all injections. These studies are methodologically flawed, and do not specifically examine vaccine injections. The present study is being undertaken to provide some preliminary data for the risk of infection and infection symptoms when alcohol swabs are not used to perform vaccine injections.
详细描述
Alcohol is used to disinfect the skin prior to injections in order to prevent infections caused by bacteria on the skin being injected within tissue. Alcohol has been shown to be a good disinfectant, reducing the number of bacteria on skin by 47-91%. However, in previous clinical trials, there has been no clinical impact of using or not using alcohol swabs on infections and infection symptoms calling into question the practice of using it prior to all injections. These studies, however, are generally of low scientific rigor (e.g., not randomized, not blinded, did not use standard case definitions of the adverse reactions being measured). Moreover, it is important to note that none of them specifically evaluated vaccine injections, the most common type of injection worldwide.
At present, based on the available evidence base, the World Health Organization (WHO) and the Centre for Disease Control (CDC) do not recommend the use of alcohol swabs before vaccine injections. As a result, immunizers in many countries around the world currently do not cleanse the skin with alcohol prior to vaccination. Despite these recommendations, clinicians in our community and across Canada commonly use alcohol swabs prior to all vaccine injections. In this application, investigators will undertake a pilot randomized study to evaluate the incidence of infection symptoms and infections in children undergoing vaccination with and without skin cleansing with alcohol swabs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, parents, care providers and outcomes assessors will not be aware of whether the participant was swabbed in the location of the vaccine injection. Only the investigator will know where alcohol was applied on the skin relative to the vaccine injection site.
入排标准
- 年龄范围
- 2 Months 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy pediatric patients undergoing routine vaccinations
排除标准
- •no contra-indications to vaccination or alcohol swab,
- •ability to understand English and consent to the study
研究组 & 干预措施
Alcohol
Alcohol will be wiped on the vaccine injection site immediately before vaccine injection.
干预措施: Alcohol (Drug)
No alcohol
Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection.
干预措施: No alcohol (Drug)
结局指标
主要结局
Skin infection
时间窗: within 14 days of injection
skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)
次要结局
- Compliance with protocol(within 30 days of injection)
- Skin infection symptoms(within 14 days of injection)
- Feasibility of recruitment(from date of first enrollment until the date of final enrollment, up to 1 year)
- Feasibility of protocol(from the date of first enrollment until the date of the last follow-up, or study completion, up to 1 year)
研究者
Anna Taddio
Professor
University of Toronto
