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Trial record 2 of 17 for:    "Connective Tissue Disease" | "Ethanol"

Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03131843
Recruitment Status : Unknown
Verified May 2017 by Anna Taddio, University of Toronto.
Recruitment status was:  Recruiting
First Posted : April 27, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Anna Taddio, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Skin Infection Drug: Alcohol Drug: No alcohol Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alcohol
Alcohol will be wiped on the vaccine injection site immediately before vaccine injection.
Drug: Alcohol
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




Primary Outcome Measures :
  1. Skin infection [ Time Frame: within 14 days of injection ]
    skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)


Secondary Outcome Measures :
  1. 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)

  2. Feasibility of recruitment [ Time Frame: from date of first enrollment until the date of final enrollment, up to 1 year ]
    recruitment rate for study

  3. Compliance with protocol [ Time Frame: within 30 days of injection ]
    rate of parent compliance with study procedures

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Anna Taddio, PhD 416-813-6235 anna.taddio@utoronto.ca
Contact: Steven Moss, MD 416-492-5888 stevenmoss@me.com

Locations
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Canada, Ontario
Pediatrician Clinic Recruiting
North York, Ontario, Canada, M2J 2K9
Contact: Horace Wong, BSc    416-492-5888    horace.wong@mail.utoronto.ca   
Contact: Anna Taddio, PhD    416-978-8822    anna.taddio@utoronto.ca   
Sponsors and Collaborators
University of Toronto
Investigators
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Principal Investigator: Anna Taddio, PhD University of Toronto

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Responsible Party: Anna Taddio, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03131843     History of Changes
Other Study ID Numbers: 33391
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anna Taddio, University of Toronto:
skin infection
vaccination
children
alcohol swab
skin preparation

Additional relevant MeSH terms:
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Connective Tissue Diseases
Ethanol
Infection
Communicable Diseases
Cellulitis
Skin Diseases, Infectious
Suppuration
Inflammation
Pathologic Processes
Skin Diseases
Vaccines
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Immunologic Factors