Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)
NCT ID: NCT05741866
Last Updated: 2023-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2023-05-03
2023-12-31
Brief Summary
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The main questions it aims to answer are:
* Study Feasibility
* Occurrence of infectious complications related to the PIVC
Participants will be randomly allocated to receive either of the below dressings to cover and secure their PIVC:
* The standard dressing used at their hospital, or
* The intervention dressing which has Chlorhexidine gluconate (CHG) on it
Researchers will compare standard and CHG dressings to see if the presence of CHG improves the occurrence of infectious complications related to the PIVC.
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Detailed Description
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Setting and sample:
Australia: The ProP Trial will be undertaken in the general medical/surgical and oncology/hematology departments at the Queensland Children's Hospital (QCH; Site 1), and the general medical/surgical departments at the Royal Brisbane and Women's Hospital (RBWH; Site 2) Brisbane, Australia. These are both large quaternary referral teaching hospitals (Site 1: 359 beds; Site 2: 929 beds).
France: The ProP Trial will be undertaken in the University Hospital of Poitiers (PUH), a large referral teaching hospital with 959 acute beds. Patients will be recruited at the Emergency Department, before being admitted to medical wards.
Sample size:
Phase 1: The investigators will recruit 300 patients (200 Australia and 100 France) with 150 patients per arm. This sample size is not determined by statistical power but to test protocol feasibility and gain estimates of effect to inform a sample size calculation for a full trial. The investigators aim to recruit 300 patients over 16 weeks (19 per week).
Phase 2: The investigators will continue recruitment to the sample size recommended by the DSMC and the Trial Steering Committee. The investigators anticipate this will be no more than a sample of 2624 patients (1312/group) which would have 90% power to detect an absolute 5% reduction in the primary outcome from 22% to 17% (2-way alpha 0.05) (http://powerandsamplesize.com/calculators).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Additionally, at the completion of Phase 1 (n=300) an independent data safety monitoring committee (DSMC) comprised of a biostatistician, physician and expert trialist, will review pre-defined blinded analyses, conducting a review of feasibility and safety data to determine if the trial should continue to a fully powered RCT.
Study Groups
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Control
Bordered Polyurethane Dressing
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
CHG Bordered Polyurethane Dressing
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
6 Years
ALL
Yes
Sponsors
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Queensland Children's Hospital
OTHER_GOV
Royal Brisbane and Women's Hospital
OTHER_GOV
University Hospital of Poitiers
UNKNOWN
Griffith University
OTHER
The University of Queensland
OTHER
Responsible Party
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Principal Investigators
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Claire Rickard
Role: PRINCIPAL_INVESTIGATOR
The University of Queensland
Locations
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Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
University Hospital of Poitiers
Poitiers, Nouvelle-Aquitaine, France
Countries
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Central Contacts
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Facility Contacts
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References
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Rickard CM, Drugeon B, Ullman A, Marsh NM, Corley A, Ball D, O'Brien C, Kleidon TM, Guenezan J, Couvreur R, McCarthy KL, Seguin S, Batiot G, Byrnes J, Schults J, Zahir SF, Mimoz O. Protect peripheral intravenous catheters: a study protocol for a randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial). BMJ Open. 2024 Jul 16;14(7):e084313. doi: 10.1136/bmjopen-2024-084313.
Other Identifiers
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2022/HE001952
Identifier Type: -
Identifier Source: org_study_id
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