Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

University of Toronto

Status and phase: Unknown; Phase 3

Conditions: Skin Infection

Treatments: Drug: No alcohol; Drug: Alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT03131843

33391

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 2 months to 18 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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170 participants in 2 patient groups, including a placebo group

Alcohol

Experimental group

Description:

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

Treatment:

Drug: Alcohol

No alcohol

Placebo Comparator group

Description:

Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection.

Treatment:

Drug: No alcohol