A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations
Overview
- Phase
- Phase 3
- Intervention
- Alcohol
- Conditions
- Skin Infection
- Sponsor
- University of Toronto
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Skin infection
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Anna Taddio
Professor
University of Toronto
Eligibility Criteria
Inclusion Criteria
- •healthy pediatric patients undergoing routine vaccinations
Exclusion Criteria
- •no contra-indications to vaccination or alcohol swab,
- •ability to understand English and consent to the study
Arms & Interventions
Alcohol
Alcohol will be wiped on the vaccine injection site immediately before vaccine injection.
Intervention: Alcohol
No alcohol
Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection.
Intervention: No alcohol
Outcomes
Primary Outcomes
Skin infection
Time Frame: within 14 days of injection
skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)
Secondary Outcomes
- 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)