Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

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.

• Alcohol (Drug): Alcohol cleansing swab/wipe
• No alcohol (Drug): No alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site

Primary outcomes

• Skin infection [within 14 days of injection]: skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)

Secondary outcomes

• Skin infection symptoms [within 14 days of injection]: skin infection symptoms (redness, swelling, pain, warmth, discharge), defined as per Brighton Collaboration definition (2007)
• Feasibility of recruitment [from date of first enrollment until the date of final enrollment, up to 1 year]: recruitment rate for study
• Compliance with protocol [within 30 days of injection]: rate of parent compliance with study procedures
• Feasibility of protocol [from the date of first enrollment until the date of the last follow-up, or study completion, up to 1 year]: descriptives of adverse events relative to follow-up

Sex: All, ages: 2 Months to 18 Years, accepts healthy volunteers

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

• Anna Taddio, PhD, Principal investigator, University of Toronto