Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

Skin Infection Clinical Trial

Official title:

A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03131843
• Other study ID #: 33391
• Status: Recruiting
• Phase: Phase 3
• First received: April 17, 2017
• Last updated: May 1, 2017
• Start date: May 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: University of Toronto
• Contact: Anna Taddio, PhD
• Phone: 416-813-6235
• Email: anna.taddio[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Skin Diseases, Infectious
• Skin Infection

Intervention

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

Locations

Country	Name	City	State
Canada	Pediatrician Clinic	North York	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin infection	skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)	within 14 days of injection
Secondary	Skin infection symptoms	skin infection symptoms (redness, swelling, pain, warmth, discharge), defined as per Brighton Collaboration definition (2007)	within 14 days of injection
Secondary	Feasibility of recruitment	recruitment rate for study	from date of first enrollment until the date of final enrollment, up to 1 year
Secondary	Compliance with protocol	rate of parent compliance with study procedures	within 30 days of injection
Secondary	Feasibility of protocol	descriptives of adverse events relative to follow-up	from the date of first enrollment until the date of the last follow-up, or study completion, up to 1 year