Recruiting
Phase 3

Alcohol Swabs

Sponsor:

University of Toronto

Code:

NCT03131843

Conditions

Skin Infection

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Alcohol

No alcohol

Study Details

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.

Conditions

Skin Infection

Study ID

NCT03131843

Start date

May 1, 2017

Status verified date

May, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Alcohol

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

placebo comparator: No alcohol

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

Interventions

Alcohol

Alcohol cleansing swab/wipe

No alcohol

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

Primary outcome measure

  • Skin infection [ Time Frame: within 14 days of injection ]

Central Contacts and Locations

Central contacts

Anna Taddio, PhD

416-813-6235anna.taddio@utoronto.ca

Steven Moss, MD

416-492-5888stevenmoss@me.com

Locations

Pediatrician Clinic

Recruiting

North York, Ontario, Canada, M2J 2K9

Contacts

Horace Wong, BSc

416-492-5888horace.wong@mail.utoronto.ca

Anna Taddio, PhD

416-978-8822anna.taddio@utoronto.ca

More Information

Sponsor

University of Toronto

Last update posted

May 2, 2017

Last verified

May, 2017

Keywords

  • skin infection
  • vaccination
  • children
  • alcohol swab
  • skin preparation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2017-05-02.