跳至主要内容
临床试验/NCT03131843
NCT03131843Unknown3 期

A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations

University of Toronto1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Alcohol will be wiped on the vaccine injection site immediately before vaccine injection.

干预措施: Alcohol (Drug)

No alcohol

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Taddio

Professor

University of Toronto

研究点 (1)

Loading locations...

相似试验

Effectiveness of Alcohol Swabs for Preventing... | 临床试验