Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

Study Overview
=================
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.

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

Conditions
-----------------
Skin Infection

Intervention / Treatment
-----------------
* Drug: Alcohol
* Drug: No alcohol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol<br>Alcohol will be wiped on the vaccine injection site immediately before vaccine injection. | Drug: Alcohol<br>* Alcohol cleansing swab/wipe<br>|
| Placebo Comparator: No alcohol<br>Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection. | Drug: No alcohol<br>* No alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin infection | skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007) | within 14 days of injection | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin infection, vaccination, children, alcohol swab, skin preparation