Clinical trial NCT03131843: Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination
Official title: A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Skin Infection
Keywords: skin infection
vaccination
children
alcohol swab
skin preparation
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 170
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Skin infection
timeFrame: within 14 days of injection
Secondary outcomes:
measure: Skin infection symptoms
timeFrame: within 14 days of injection
measure: Feasibility of recruitment
timeFrame: from date of first enrollment until the date of final enrollment, up to 1 year
measure: Compliance with protocol
timeFrame: within 30 days of injection
measure: Feasibility of protocol
timeFrame: from the date of first enrollment until the date of the last follow-up, or study completion, up to 1 year
Other outcomes:
Locations:
city: North York
country: Canada
facility: Pediatrician Clinic
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References: