Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

NCT03131843 | Unknown Phase 3 DMC

• 1 other identifier: 33391
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Keywords

skin infection; vaccination; children; alcohol swab; skin preparation

Outcome Measures

Primary Outcomes (1)

• Skin infection

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

  within 14 days of injection

Secondary Outcomes (4)

• Skin infection symptoms

  within 14 days of injection

• Feasibility of recruitment

  from date of first enrollment until the date of final enrollment, up to 1 year

• Compliance with protocol

  within 30 days of injection

• Feasibility of protocol

  from the date of first enrollment until the date of the last follow-up, or study completion, up to 1 year

Study Arms (2)

Alcohol

EXPERIMENTAL

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

Drug: Alcohol

No alcohol

PLACEBO COMPARATOR

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

Drug: No alcohol

Interventions

Alcohol DRUG

Alcohol cleansing swab/wipe

Alcohol

No alcohol DRUG

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

No alcohol

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• healthy pediatric patients undergoing routine vaccinations

You may not qualify if:

• no contra-indications to vaccination or alcohol swab,
• ability to understand English and consent to the study

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Pediatrician Clinic

North York, Ontario, M2J 2K9, Canada

RECRUITING

MeSH Terms

Conditions

Cellulitis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Anna Taddio, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Taddio, PhD

CONTACT

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

Steven Moss, MD

CONTACT

416-492-5888; stevenmoss@me.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel randomized controlled trial

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 27, 2017
• Study Start: May 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 2, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)