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Trial registered on ANZCTR


Registration number
ACTRN12619001366145p
Ethics application status
Submitted, not yet approved
Date submitted
28/08/2019
Date registered
8/10/2019
Date last updated
8/10/2019
Date data sharing statement initially provided
8/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Alternative topical treatments for school sores.
Scientific title
Comparison of topical antibiotics with topical antiseptics and inert ointment for treatment of impetigo – protocol for a pilot prospective randomised double-blinded controlled trial for the topical treatment of impetigo in Australian general practice.
Secondary ID [1] 299120 0
Nil known
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Impetigo 314182 0
Antimicrobial Stewardship 314183 0
Condition category
Condition code
Skin 312540 312540 0 0
Dermatological conditions
Infection 312541 312541 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Hydrogen peroxide ointment applied to skin lesions with cotton bud, three times a day for 5 days, by the participant or their guardian if the participant is a child. All lesions to be covered with standardised dressings provided, dressing changes will occur at every application. Adherence will be monitored by use of a treatment diary to be completed by the participant and returned to the treating doctor at the completion of the intervention.
2. Soft white paraffin ointment applied to skin lesions with cotton bud, three times a day for 5 days, by the participant or their guardian if the participant is a child. All lesions to be covered with standardised dressings provided, dressing changes will occur at every application. Adherence will be monitored by use of a treatment diary to be completed by the participant and returned to the treating doctor at the completion of the intervention.
Intervention code [1] 315389 0
Treatment: Other
Comparator / control treatment
Mupirocin ointment applied to skin lesions with cotton bud, three times a day for 5 days, by the participant or their guardian if the participant is a child. All lesions to be covered with standardised dressings provided, dressing changes will occur at every application. Adherence will be monitored by use of a treatment diary to be completed by the participant and returned to the treating doctor at the completion of the intervention. .
Control group
Active

Outcomes
Primary outcome [1] 321188 0
The primary outcome measure is the number of lesions as determined by the GP. In addition, lesion photographs will be assessed by two blinded independent outcome assessors to improve validity and reliability.
Timepoint [1] 321188 0
Day 6 post commencement of intervention.
Primary outcome [2] 321391 0
The primary outcome measure is the size of lesions as determined by the GP. Wound size will be determined by measurement of the lesion in two perpendicular axes. In addition, lesion photographs will be assessed by two blinded independent outcome assessors to improve validity and reliability.
Timepoint [2] 321391 0
Day 6 post commencement of intervention.
Secondary outcome [1] 374248 0
Treatment compliance as measured by treatment diary provided to patients
Timepoint [1] 374248 0
Day 6 post commencement of intervention.
Secondary outcome [2] 374249 0
Adverse reactions (e.g. anaphylaxis, skin irritation, dermatitis, rash) as determined by patient report and clinician assessment documented on data collection form.
Timepoint [2] 374249 0
Day 6 post commencement of intervention or patient may present sooner.
Secondary outcome [3] 374250 0
Microbial aetiology as shown on wound swab MCS taken at Day 0.
Timepoint [3] 374250 0
Swab collected on Day 0 and result reviewed when available, likely Day 3-5 post commencement of intervention
Secondary outcome [4] 374251 0
Feasibility of trial as assessed during focus groups of participating GPs to assess the acceptability of the treatment and study protocol and potential barriers to participation. Participant feedback of the treatment regime will be collected via a short survey in their treatment diary. Recruitment rate will also be calculated.
Timepoint [4] 374251 0
9 months post commencement of recruitment.
Secondary outcome [5] 374849 0
Patterns of microbial resistance as shown on wound swab MCS taken at day 0.
Timepoint [5] 374849 0
Swab collected on Day 0 and result reviewed when available, likely Day 3-5 post commencement of intervention

Eligibility
Key inclusion criteria
• <4 skin lesions
• Lesions able to be covered with dressings
• No allergy to Mupirocin®, hydrogen peroxide or soft white paraffin ointments
• No current use of antibiotics
• No use of topical therapeutic agents on lesions within the last 48 hours
• No Concomitant underlying skin disease (e.g. eczematous dermatitis)
• Immuno-compotent
• Patients with a primary language is English or for which certifed translation services for that language are available
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Systemic infection (e.g. fever, nausea, vomiting)
• Aboriginal or Torres Strait Islander ethnicity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be attained by using sealed, numbered, tamperproof opaque envelopes such that patients and clinicians will be blinded to allocation. The research team involved in the assessment or treatment of patients will have no role in the assignment process. The Investigators assessing the digital images will be blinded to treatment allocation and the time at which images were taken (baseline or follow up).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary analysis of treatment effect is an intention-to-treat analysis of all randomised participants. The analysis will be performed taking the individual person as the unit of analysis. All p values will be two tailed and p<0.05 considered statistically significant. Baseline data across control and intervention groups will be assessed for heterogeneity. The incidence of treatment success will be compared using Pearson’s chi-square test. We will perform sensitivity testing for patients lost to follow-up and per protocol analysis for non-compliers to assess for the possible effects of systematic biases on results.

The main aim of this pilot study is to assess trial feasibility. Quantitative results will inform the sample size calculation for a future RCT but we will not have statistical power to draw conclusions about treatment efficacy. We will arbitrarily recruit 30 patients, 10 for each arm, sufficient to assess protocol acceptability and provide insight into treatment efficacy. An additional 3 patients will be recruited to counter potential attrition, providing a final sample size of 33.
Recruitment rate and treatment/protocol compliance will be analysed descriptively, and participant perceptions and acceptability of the intervention will undergo qualitative analysis to inform and guide a future RCT.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
1/11/2020
Actual
Date of last data collection
Anticipated
8/11/2020
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 27674 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 303663 0
Charities/Societies/Foundations
Name [1] 303663 0
RACGP Foundation
Country [1] 303663 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Dr, Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 303753 0
Individual
Name [1] 303753 0
Hilary Gorges
Address [1] 303753 0
James Cook University Mackay Campus, 475 Bridge Rd, Mackay QLD 4740
Country [1] 303753 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304183 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 304183 0
Ethics committee country [1] 304183 0
Australia
Date submitted for ethics approval [1] 304183 0
18/09/2019
Approval date [1] 304183 0
Ethics approval number [1] 304183 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96070 0
Dr Hilary Gorges
Address 96070 0
James Cook University Mackay Campus 475 Bridge Rd, Mackay QLD 4740
Country 96070 0
Australia
Phone 96070 0
+61 409406965
Fax 96070 0
Email 96070 0
[email protected]
Contact person for public queries
Name 96071 0
Hilary Gorges
Address 96071 0
James Cook University Mackay Campus 475 Bridge Rd, Mackay QLD 4740
Country 96071 0
Australia
Phone 96071 0
+61 409406965
Fax 96071 0
Email 96071 0
[email protected]
Contact person for scientific queries
Name 96072 0
Hilary Gorges
Address 96072 0
James Cook University Mackay Campus 475 Bridge Rd, Mackay QLD 4740
Country 96072 0
Australia
Phone 96072 0
+61 409406965
Fax 96072 0
Email 96072 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data will be available to response to reasonable requests.
When will data be available (start and end dates)?
The data will be available after the study has been accepted for publication. Data will be available for 5 years following main results publication.
Available to whom?
To reasonable requests from relevant organisation
Available for what types of analyses?
For IPD meta-analysis
How or where can data be obtained?
email request to principle author ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEmerging Treatment Strategies for Impetigo in Endemic and Nonendemic Settings: A Systematic Review.2021https://dx.doi.org/10.1016/j.clinthera.2021.04.013
EmbaseFeasibility study for a randomised controlled trial for the topical treatment of impetigo in australian general practice.2021https://dx.doi.org/10.3390/tropicalmed6040197
N.B. These documents automatically identified may not have been verified by the study sponsor.