Skin InfectionPhase 3NCT03131843
Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination
A Phase 3 study testing Alcohol and No alcohol in people with Skin Infection, run by University of Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Infection
- What is being tested?
- Alcohol and No alcohol
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy pediatric patients undergoing routine vaccinations
Who cannot join
- no contra-indications to vaccination or alcohol swab,
- ability to understand English and consent to the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Pediatrician Clinic
North York, Ontario, M2J 2K9
Horace Wong, BSc, 416-492-5888, horace.wong@mail.utoronto.ca
Anna Taddio, PhD, 416-978-8822, anna.taddio@utoronto.ca
About this study
Official title: A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations
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.
Read the 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.
- Conditions
- Skin Infection
- Being tested
- Alcohol, No alcohol
- Keywords
- skin infection, vaccination, children, alcohol swab, skin preparation
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Alcohol cleansing swab/wipe
No alcoholDrug
No alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site
| Study group | Role | What they receive |
|---|---|---|
| Alcohol | Experimental | Alcohol will be wiped on the vaccine injection site immediately before vaccine injection. Receives: Drug: Alcohol |
| No alcohol | Placebo comparator | Alcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection. Receives: Drug: No alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin infection
skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)
Measured: within 14 days of injection
Secondary outcomes (4)
Skin infection symptoms
skin infection symptoms (redness, swelling, pain, warmth, discharge), defined as per Brighton Collaboration definition (2007)
Measured: within 14 days of injection
Feasibility of recruitment
recruitment rate for study
Measured: from date of first enrollment until the date of final enrollment, up to 1 year
Compliance with protocol
rate of parent compliance with study procedures
Measured: within 30 days of injection
Feasibility of protocol
descriptives of adverse events relative to follow-up
Measured: from the date of first enrollment until the date of the last follow-up, or study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 May 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InfectionStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Taddio, University of Toronto
- Investigators
- Anna Taddio, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131843
- Sponsor's protocol ID
- 33391
- Status last verified
- May 2017
- First submitted
- 17 Apr 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Assessing the Effectiveness of Alcohol Swabs in Preventing Infections in Pediatric Patients Receiving Vaccinations
- ClinicalTrials.gov ID
- NCT03131843
- Acronym / sponsor ID
- 33391
- Conditions
- Skin Infection
- Keywords
- skin infection, vaccination, children, alcohol swab, skin preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Alcohol | Experimental | Drug: AlcoholAlcohol will be wiped on the vaccine injection site immediately before vaccine injection. |
| No alcohol | Placebo comparator | Drug: No alcoholAlcohol will be wiped adjacent to the vaccine injection site immediately before vaccine injection. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- healthy pediatric patients undergoing routine vaccinations
Key exclusion criteria (2 listed)
- no contra-indications to vaccination or alcohol swab,
- ability to understand English and consent to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholAlcohol cleansing swab/wipe | Drug | Alcohol |
| No alcoholNo alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site | Drug | No alcohol |
Primary outcome
Skin infection
Time frame: within 14 days of injection
skin infection (cellulitis, abscess), defined as per Brighton Collaboration definition (2007)
4 secondary outcomes
Skin infection symptoms
Time frame: within 14 days of injection
Feasibility of recruitment
Time frame: from date of first enrollment until the date of final enrollment, up to 1 year
Compliance with protocol
Time frame: within 30 days of injection
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Taddio, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alcohol and No alcohol in people with Skin Infection, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Taddio, PhD (416-813-6235, anna.taddio@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin infection (time frame: within 14 days of injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.