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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)
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Scientific title
Protect PIVCs: An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs).
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Secondary ID [1]
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2022/HE001952
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Universal Trial Number (UTN)
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Trial acronym
ProP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vascular Access Complication
0
0
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Device Related Infection
0
0
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Device Related Sepsis
0
0
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Device Site Reactions
0
0
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Catheter Infection
0
0
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Catheter Complications
0
0
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Catheter-Related Infections
0
0
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Catheter Related Complication
0
0
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Occlusive Dressings
0
0
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Wound Infection
0
0
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Wound of Skin
0
0
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Wound
0
0
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Condition category
Condition code
Infection
0
0
0
0
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Studies of infection and infectious agents
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Infection
0
0
0
0
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Other infectious diseases
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Infection
0
0
0
0
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Sexually transmitted infections
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Renal and Urogenital
0
0
0
0
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Other renal and urogenital disorders
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Public Health
0
0
0
0
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Health service research
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Public Health
0
0
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0
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Other public health
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Skin
0
0
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility for a definitive RCT
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Assessment method [1]
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The feasibility of conducting a definitive RCT will be assessed against the following criteria:
i. Study Eligibility as per inclusion/exclusion criteria (=80% of screened participants will be eligible for study inclusion) ii. Participant Recruitment onto study (=80% of eligible participants will provide informed consent to participate in the study) iii. Retention of study participants (\<10% will be lost to follow up) iv. Protocol fidelity of study participants (=80% will receive the allocated intervention) v. Missing data for primary outcome 2 (\<5% of primary outcome 2 data will be unable to be collected) vi. Satisfaction of participants/parents and staff (\<10% report "low" satisfaction with the intervention arm (rated low/medium/high) vii. An estimate of catheter-related infectious complications (defined as per primary outcome 2) in the control group that indicate a fully powered multi-site RCT is achievable
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Timepoint [1]
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On completion of 300 participants
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Primary outcome [2]
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Catheter-related infectious complications and phlebitis
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Assessment method [2]
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Proportion of patients with a composite measure of PIVC Colonization; PIVC local infection; PIVC-associated Bloodstream Infection (BSI) and Phlebitis. These measures are defined below in secondary outcomes.
If patients meet more than one of the following \[e.g., phlebitis and PIVC local infection\], both will be collected however only counted once for the composite measure.
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Timepoint [2]
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Daily until 48hours after study PIVC is removed.
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Secondary outcome [1]
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PIVC tip colonization
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Assessment method [1]
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\>15 cfu of a pathogen semi-quantitative method, or =1000 cfu of a pathogen per mL broth method.
PIVC tips will be collected based on Nurse and laboratory availability at time of PIVC removal.
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Timepoint [1]
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Daily until 48hours after study PIVC is removed.
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Secondary outcome [2]
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PIVC local infection without Bloodstream Infection (BSI)
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Assessment method [2]
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Proportion of patients with a PIVC local infection without BSI as defined by NHSN 2021 criteria for Cardiovascular System VASC-Arterial or Venous Infection (CVS-VASC); adult and child/infant criteria.
Collected daily by either the research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record and microbiology results.
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Timepoint [2]
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0
Daily until 48hours after study PIVC is removed.
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Secondary outcome [3]
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PIVC-associated Bloodstream Infection
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Assessment method [3]
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Proportion of patients with a laboratory Confirmed Bloodstream Infection, as defined by NHSN 2021 adult and infant criteria
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record and microbiology results.
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Timepoint [3]
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Daily until 48hours after study PIVC is removed.
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Secondary outcome [4]
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Phlebitis
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Assessment method [4]
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Either pain or tenderness \[\>1 on a scale of 0 to 10\]), or at least 2 of erythema, swelling, purulence or palpable cord.
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
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Timepoint [4]
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Daily until 48hours after study PIVC is removed.
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Secondary outcome [5]
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PIVC device failure
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Assessment method [5]
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Proportion of patients, a composite of infiltration/ extravasation, blockage/occlusion (with/without leakage), phlebitis (as defined above), thrombosis, dislodgement (complete/partial) or infection (as defined above).
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
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Timepoint [5]
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Daily until 48hours after study PIVC is removed.
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Secondary outcome [6]
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Dressing durability
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Assessment method [6]
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Proportion of patients with dressing durability assessed as:
(i) the dressing remains adhered to the skin on all four sides until PIVC removal; and, (ii) accidental dislodgement (excluding patients who deliberately remove their PIVC).
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
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Timepoint [6]
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Daily until study PIVC is removed.
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Secondary outcome [7]
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Skin colonization
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Assessment method [7]
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Reported semi-quantitatively as scant, 1+, 2+, 3.
PIVC skin swabs will be collected based on Nurse and laboratory availability at time of PIVC removal.
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Timepoint [7]
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On study PIVC removal
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Secondary outcome [8]
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Adverse skin event
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Assessment method [8]
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Proportion of patients with skin complications at PIVC site: mechanical (e.g. pressure injury, skin tears, blisters, bruising) or inflammatory complications (e.g. contact/allergic dermatitis, skin rash, pruritus).
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
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Timepoint [8]
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Daily until 48hours after study PIVC is removed.
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Secondary outcome [9]
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Serious adverse event
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Assessment method [9]
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Proportion of patients with anaphylactic reaction to CHG in dressing; or mortality related to PIVC infection.
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
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Timepoint [9]
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Daily until 48hours after study PIVC is removed.
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Secondary outcome [10]
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Cost effectiveness
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Assessment method [10]
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Direct and indirect healthcare costs to the health system, including cost per complication avoided.
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record and microbiology results.
A random subset of 15% of participants will have all subsequent devices recorded until completion of treatment for the participant's current admission. Date of discharge will be recorded for all participants to calculate length of stay.
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Timepoint [10]
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Until discharge.
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Secondary outcome [11]
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Patient reported experience measures of the dressing
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Assessment method [11]
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Proportion of participants/parents who report their satisfaction with the dressing rated low/medium/high with respective prompts of:
1. "I'd rather use a different dressing next time"
2. "The dressing was ok, but I'm happy to try other types"
3. "It was a really good dressing and I'd like to use this one again"
A Patient-Reported Experience Measure survey will be conducted on study PIVC removal.
Patient's will have the opportunity to comment on the dressing and their satisfaction with it at any time during study participation.
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Timepoint [11]
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Daily until 48hours after study PIVC is removed.
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Secondary outcome [12]
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Clinician reported experience measures of the dressing including application and removal
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Assessment method [12]
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Proportion of clinicians who report their satisfaction with the dressing rated low/medium/high with respective prompts of:
1. "I'd rather use a different dressing next time"
2. "The dressing was ok, but I'm happy to try other types"
3. "It was a really good dressing and I'd like to use this one again"
Collected opportunistically between dressing application to 48 hours after study PIVC removal.
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Timepoint [12]
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Daily until 48hours after study PIVC is removed.
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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
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Minimum age
6
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2023
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [2]
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Queensland Children's Hospital - South Brisbane
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Nouvelle-Aquitaine
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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0
Other
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Name [1]
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Queensland Children's Hospital
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
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0
Government body
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Name [2]
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Royal Brisbane and Women's Hospital
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Address [2]
0
0
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Country [2]
0
0
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Other collaborator category [3]
0
0
Other
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Name [3]
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University Hospital of Poitiers
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Address [3]
0
0
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Country [3]
0
0
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Other collaborator category [4]
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Other
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Name [4]
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Griffith University
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Address [4]
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0
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Country [4]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this clinical trial is to compare a chlorhexidine impregnated dressing for peripheral intravenous catheters (PIVCs) to the standard dressing currently used in general medical and surgical inpatient wards. 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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Trial website
https://clinicaltrials.gov/study/NCT05741866
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Claire Rickard
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Address
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The University of Queensland
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
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ProP - Project Manager
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Address
0
0
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Country
0
0
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Phone
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+61 (0) 7 36467671
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Available to individuals who provide a methodologically sound proposal and at the discretion of the Principal Investigator.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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
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Prof
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Name
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Claire Rickard
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Address
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University of Queensland Centre for Clinical Research Herston QLD 4006 Australia
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Country
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Australia
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Phone
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+61413398482
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Fax
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0
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Email
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0
[email protected]
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Contact person for public queries
Title
378
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Ms
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Name
378
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Catherine O'Brien
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Address
378
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Metro North Hospitals and Health Service UQ Centre for Clinical Research Herston QLD 4006
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Country
378
0
Australia
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Phone
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0
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Fax
378
0
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Email
378
0
[email protected]
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Contact person for scientific queries
Title
379
0
Prof
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Name
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Claire Rickard
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Address
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University of Queensland Centre for Clinical Research Herston QLD 4006 Australia
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Country
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Australia
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Phone
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+61413398482
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Fax
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0
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Email
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0
[email protected]
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