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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05741866


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05741866
Ethics application status
Date submitted
15/12/2022
Date registered
23/02/2023

Titles & IDs
Public title
Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)
Scientific title
Protect PIVCs: An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs).
Secondary ID [1] 0 0
2022/HE001952
Universal Trial Number (UTN)
Trial acronym
ProP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular Access Complication 0 0
Device Related Infection 0 0
Device Related Sepsis 0 0
Device Site Reactions 0 0
Catheter Infection 0 0
Catheter Complications 0 0
Catheter-Related Infections 0 0
Catheter Related Complication 0 0
Occlusive Dressings 0 0
Wound Infection 0 0
Wound of Skin 0 0
Wound 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Public Health 0 0 0 0
Health service research
Public Health 0 0 0 0
Other public health
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Chlorhexidine gluconate impregnated bordered polyurethane dressing
Treatment: Devices - Standard bordered polyurethane dressing

Active comparator: Control - Bordered Polyurethane Dressing

Experimental: Intervention - CHG Bordered Polyurethane Dressing


Treatment: Devices: Chlorhexidine gluconate impregnated bordered polyurethane dressing
PIVCs will be dressed and secured at the participating sites

* RBWH and PUH: PIVCs will be dressed with Tegaderm™ Antimicrobial I.V. Advanced Securement (9132) dressing and secured with non-sterile tape over extension tubing.
* QCH: PIVCs will be dressed with Tegaderm™ Antimicrobial I.V. Advanced Securement (9132) dressing and secured with tubular bandage +/- arm board and non-sterile stretchy tape if PIVC over flexible joint, +/- tissue adhesive as per clinician preference.

Treatment: Devices: Standard bordered polyurethane dressing
PIVCs will be dressed and secured as per standard practice at the participating sites

* RBWH and PUH: Bordered polyurethane dressing (Tegaderm™ IV Advanced 1683) and non-sterile tape strip over extension tubing.
* QCH: Bordered polyurethane dressing (Tegaderm™ IV Advanced 1682 or 1683) and secured with tubular bandage +/- arm board and non-sterile stretchy tape if PIVC over flexible joint, +/- tissue adhesive as per clinician preference.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility for a definitive RCT
Timepoint [1] 0 0
On completion of 300 participants
Primary outcome [2] 0 0
Catheter-related infectious complications and phlebitis
Timepoint [2] 0 0
Daily until 48hours after study PIVC is removed.
Secondary outcome [1] 0 0
PIVC tip colonization
Timepoint [1] 0 0
Daily until 48hours after study PIVC is removed.
Secondary outcome [2] 0 0
PIVC local infection without Bloodstream Infection (BSI)
Timepoint [2] 0 0
Daily until 48hours after study PIVC is removed.
Secondary outcome [3] 0 0
PIVC-associated Bloodstream Infection
Timepoint [3] 0 0
Daily until 48hours after study PIVC is removed.
Secondary outcome [4] 0 0
Phlebitis
Timepoint [4] 0 0
Daily until 48hours after study PIVC is removed.
Secondary outcome [5] 0 0
PIVC device failure
Timepoint [5] 0 0
Daily until 48hours after study PIVC is removed.
Secondary outcome [6] 0 0
Dressing durability
Timepoint [6] 0 0
Daily until study PIVC is removed.
Secondary outcome [7] 0 0
Skin colonization
Timepoint [7] 0 0
On study PIVC removal
Secondary outcome [8] 0 0
Adverse skin event
Timepoint [8] 0 0
Daily until 48hours after study PIVC is removed.
Secondary outcome [9] 0 0
Serious adverse event
Timepoint [9] 0 0
Daily until 48hours after study PIVC is removed.
Secondary outcome [10] 0 0
Cost effectiveness
Timepoint [10] 0 0
Until discharge.
Secondary outcome [11] 0 0
Patient reported experience measures of the dressing
Timepoint [11] 0 0
Daily until 48hours after study PIVC is removed.
Secondary outcome [12] 0 0
Clinician reported experience measures of the dressing including application and removal
Timepoint [12] 0 0
Daily until 48hours after study PIVC is removed.

Eligibility
Key inclusion criteria
* PIVC to be inserted with expected dwell >48 hours
* Provided written and informed consent (patient or carer)

Australia only

• =6 years of age (due to size of dressing)

France only

• =18 years of age
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Burned, non-intact or scarred skin at the insertion site
* Known allergy to CHG or transparent dressing adhesives
* Palliative care patients on end-of-life pathway
* Patient who has already participated in the study
* Placement of a PIVC in an emergency, that does not allow the usual rules of hygiene for insertion to be adhered to.

Additional exclusions to Australian study only

* Non-English-speaking patients without interpreter
* Under the care of Child and Family Services and unable to gain consent from case worker (paediatric patients)

Additional exclusions to French study only

* Patients not benefiting from the French Social Security scheme or not benefiting from it through a third party,
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
* Known pregnant or breastfeeding women
* Predictably difficult vascular access (IV drug addiction, obesity)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Nouvelle-Aquitaine

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland Children's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Royal Brisbane and Women's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University Hospital of Poitiers
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Griffith University
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Claire Rickard
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ProP - Project Manager
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 7 36467671
Fax 0 0
Email 0 0
catherine.obrien2@health.qld.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Available to individuals who provide a methodologically sound proposal and at the discretion of the Principal Investigator.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05741866

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 130
Queensland Children's Hospital
Recruitment hospital [2] 131
Royal Brisbane & Womens Hospital
Recruitment postcode(s) [1] 132
4101
Recruitment postcode(s) [2] 133
4029
Funding & Sponsors
Funding source category [1] 83
Commercial sector/Industry
Name [1] 83
3M Company
Address [1] 83
3M Health Care, Health Care Business Group 6203 Farinon Drive, Office 409 San Antonio, Texas 78249 | US
Country [1] 83
United States of America
Primary sponsor
University
Primary sponsor name
The University of Queensland
Primary sponsor address
The University of Queensland
Brisbane QLD 4072 Australia
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 58
CHILDREN’S HEALTH QUEENSLAND HOSPITAL AND HEALTH SERVICE HUMAN RESEARCH ETHICS COMMITTEE
Address [1] 58
Level 7, Centre for Children’s Health Research Queensland Children’s Hospital Precinct 62 Graham Street, South Brisbane QLD 4101
Country [1] 58
Australia
Date submitted for ethics approval [1] 58
13/12/2022
Approval date [1] 58
14/12/2022
Ethics approval number [1] 58
HREC/22/QCHQ/85411
 
Public notes

Contacts
Principal investigator
Title 377 0
Prof
Name 377 0
Claire Rickard
Address 377 0
University of Queensland Centre for Clinical Research Herston QLD 4006 Australia
Country 377 0
Australia
Phone 377 0
+61413398482
Fax 377 0
Email 377 0
c.rickard@uq.edu.au
Contact person for public queries
Title 378 0
Ms
Name 378 0
Catherine O'Brien
Address 378 0
Metro North Hospitals and Health Service UQ Centre for Clinical Research Herston QLD 4006
Country 378 0
Australia
Phone 378 0
Fax 378 0
Email 378 0
catherine.obrien2@health.qld.gov.au
Contact person for scientific queries
Title 379 0
Prof
Name 379 0
Claire Rickard
Address 379 0
University of Queensland Centre for Clinical Research Herston QLD 4006 Australia
Country 379 0
Australia
Phone 379 0
+61413398482
Fax 379 0
Email 379 0
c.rickard@uq.edu.au