search
Back to results

Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

Primary Purpose

Skin Infection

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Alcohol
No alcohol
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Infection focused on measuring skin infection, vaccination, children, alcohol swab, skin preparation

Eligibility Criteria

2 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pediatrician ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alcohol

No alcohol

Arm Description

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

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

Outcomes

Primary Outcome Measures

Skin infection
skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)

Secondary Outcome Measures

Skin infection symptoms
skin infection symptoms (redness, swelling, pain, warmth, discharge), defined as per Brighton Collaboration definition (2007)
Feasibility of recruitment
recruitment rate for study
Compliance with protocol
rate of parent compliance with study procedures
Feasibility of protocol
descriptives of adverse events relative to follow-up

Full Information

First Posted
April 17, 2017
Last Updated
May 1, 2017
Sponsor
University of Toronto
search

1. Study Identification

Unique Protocol Identification Number
NCT03131843
Brief Title
Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination
Official Title
A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Infection
Keywords
skin infection, vaccination, children, alcohol swab, skin preparation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled trial
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol
Arm Type
Experimental
Arm Description
Alcohol will be wiped on the vaccine injection site immediately before vaccine injection.
Arm Title
No alcohol
Arm Type
Placebo Comparator
Arm Description
Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection.
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
Alcohol cleansing swab/wipe
Intervention Type
Drug
Intervention Name(s)
No alcohol
Intervention Description
No alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site
Primary Outcome Measure Information:
Title
Skin infection
Description
skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)
Time Frame
within 14 days of injection
Secondary Outcome Measure Information:
Title
Skin infection symptoms
Description
skin infection symptoms (redness, swelling, pain, warmth, discharge), defined as per Brighton Collaboration definition (2007)
Time Frame
within 14 days of injection
Title
Feasibility of recruitment
Description
recruitment rate for study
Time Frame
from date of first enrollment until the date of final enrollment, up to 1 year
Title
Compliance with protocol
Description
rate of parent compliance with study procedures
Time Frame
within 30 days of injection
Title
Feasibility of protocol
Description
descriptives of adverse events relative to follow-up
Time Frame
from the date of first enrollment until the date of the last follow-up, or study completion, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Taddio, PhD
Phone
416-813-6235
Email
anna.taddio@utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Moss, MD
Phone
416-492-5888
Email
stevenmoss@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Taddio, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatrician Clinic
City
North York
State/Province
Ontario
ZIP/Postal Code
M2J 2K9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horace Wong, BSc
Phone
416-492-5888
Email
horace.wong@mail.utoronto.ca
First Name & Middle Initial & Last Name & Degree
Anna Taddio, PhD
Phone
416-978-8822
Email
anna.taddio@utoronto.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available to other researchers.

Learn more about this trial

Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

We'll reach out to this number within 24 hrs