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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol | Experimental | Alcohol will be wiped on the vaccine injection site immediately before vaccine injection. |
|
| No alcohol | Placebo Comparator | Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Drug | Alcohol cleansing swab/wipe |
| |
| No alcohol |
| Measure | Description | Time Frame |
|---|---|---|
| Skin infection | skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007) | within 14 days of injection |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Taddio, PhD | Contact | 416-813-6235 | anna.taddio@utoronto.ca | |
| Steven Moss, MD | Contact | 416-492-5888 | stevenmoss@me.com |
| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatrician Clinic | Recruiting | North York | Ontario | M2J 2K9 | Canada |
There is no plan to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Parallel randomized controlled trial
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Participants, parents, care providers and outcomes assessors will not be aware of whether the participant was swabbed in the location of the vaccine injection. Only the investigator will know where alcohol was applied on the skin relative to the vaccine injection site.
| Drug |
No alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site |
|
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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |