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Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

NCT ID: NCT03131843

Last Updated: 2017-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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. 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.

Conditions

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Skin Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Alcohol

Alcohol will be wiped on the vaccine injection site immediately before vaccine injection.

Group Type EXPERIMENTAL

Alcohol

Intervention Type DRUG

Alcohol cleansing swab/wipe

No alcohol

Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection.

Group Type PLACEBO_COMPARATOR

No alcohol

Intervention Type DRUG

No alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site

Interventions

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Alcohol

Alcohol cleansing swab/wipe

Intervention Type DRUG

No alcohol

No alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Anna Taddio

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Taddio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Pediatrician Clinic

North York, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Anna Taddio, PhD

Role: CONTACT

[email protected]
416-813-6235

Steven Moss, MD

Role: CONTACT

[email protected]
416-492-5888

Facility Contacts

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Horace Wong, BSc

Role: primary

[email protected]
416-492-5888

Anna Taddio, PhD

Role: backup

[email protected]
416-978-8822

Other Identifiers

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33391

Identifier Type: -

Identifier Source: org_study_id

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