Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination
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|ClinicalTrials.gov Identifier: NCT03131843|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : May 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Skin Infection||Drug: Alcohol Drug: No alcohol||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel randomized controlled trial|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Alcohol will be wiped on the vaccine injection site immediately before vaccine injection.
Alcohol cleansing swab/wipe
Placebo Comparator: No alcohol
Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection.
Drug: No alcohol
No alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site
- Skin infection [ Time Frame: within 14 days of injection ]skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131843
|Contact: Anna Taddio, PhDfirstname.lastname@example.org|
|Contact: Steven Moss, MDemail@example.com|
|North York, Ontario, Canada, M2J 2K9|
|Contact: Horace Wong, BSc 416-492-5888 firstname.lastname@example.org|
|Contact: Anna Taddio, PhD 416-978-8822 email@example.com|
|Principal Investigator:||Anna Taddio, PhD||University of Toronto|