Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

Overview

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 Title of Study: “A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Study Primary Completion Date: December 2018

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.

Interventions

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

Arms, Groups and Cohorts

• Experimental: Alcohol
  • Alcohol will be wiped on the vaccine injection site immediately before vaccine injection.
• Placebo Comparator: No alcohol
  • Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

• Skin infection symptoms
  • Time Frame: within 14 days of injection
  • skin infection symptoms (redness, swelling, pain, warmth, discharge), defined as per Brighton Collaboration definition (2007)
• Feasibility of recruitment
  • Time Frame: from date of first enrollment until the date of final enrollment, up to 1 year
  • recruitment rate for study
• Compliance with protocol
  • Time Frame: within 30 days of injection
  • rate of parent compliance with study procedures
• Feasibility of protocol
  • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Months

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • University of Toronto
• Provider of Information About this Clinical Study
  • Principal Investigator: Anna Taddio, Professor – University of Toronto
• Overall Official(s)
  • Anna Taddio, PhD, Principal Investigator, University of Toronto
• Overall Contact(s)
  • Anna Taddio, PhD, 416-813-6235, anna.taddio@utoronto.ca