Clinical trial NCT05741866: Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)
Official title: Protect PIVCs: An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Access Complication
Device Related Infection
Device Related Sepsis
Device Site Reactions
Catheter Infection
Catheter Complications
Catheter-Related Infections
Catheter Related Complication
Occlusive Dressings
Wound Infection
Wound of Skin
Wound
Keywords: Peripheral Intravenous Catheter
PIVC
Intravenous
Vascular access device
randomised controlled trial
phlebitis
chlorhexidine gluconate
CHG dressing
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Queensland Children's Hospital
name: Royal Brisbane and Women's Hospital
name: University Hospital of Poitiers
name: Griffith University
First posted: 2023-02-23
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-centre, two-arm, parallel group adaptive randomised controlled trial
Primary purpose: PREVENTION

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.

Detailed description: This study is a multi-centre, two-arm, parallel group adaptive Randomized Controlled Trial (RCT) to test effectiveness, cost-effectiveness, and safety of 3M™ Tegaderm™ Antimicrobial IV Advanced Securement dressings with standard polyurethane dressings for PIVCs. The study has two phases. Phase I is an internal feasibility pilot for which only feasibility outcomes will be considered (no analysis). At this time (n=300) an independent Data Safety Monitoring Committee (DSMC) comprised of a biostatistician, physician and expert trialist will review pre-defined blinded analyses of feasibility and safety data. Phase II will then go ahead if feasibility outcomes are satisfactory, and will involve continuation of trial recruitment to complete a definitive RCT. If Phase II does not proceed then all outcomes will be reported at the end of Phase I.

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).

Eligibility criteria: 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

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)

Primary outcomes:
measure: Feasibility for a definitive RCT
timeFrame: On completion of 300 participants
measure: Catheter-related infectious complications and phlebitis
timeFrame: Daily until 48hours after study PIVC is removed.
Secondary outcomes:
measure: PIVC tip colonization
timeFrame: Daily until 48hours after study PIVC is removed.
measure: PIVC local infection without Bloodstream Infection (BSI)
timeFrame: Daily until 48hours after study PIVC is removed.
measure: PIVC-associated Bloodstream Infection
timeFrame: Daily until 48hours after study PIVC is removed.
measure: Phlebitis
timeFrame: Daily until 48hours after study PIVC is removed.
measure: PIVC device failure
timeFrame: Daily until 48hours after study PIVC is removed.
measure: Dressing durability
timeFrame: Daily until study PIVC is removed.
measure: Skin colonization
timeFrame: On study PIVC removal
measure: Adverse skin event
timeFrame: Daily until 48hours after study PIVC is removed.
measure: Serious adverse event
timeFrame: Daily until 48hours after study PIVC is removed.
measure: Cost effectiveness
timeFrame: Until discharge.
measure: Patient reported experience measures of the dressing
timeFrame: Daily until 48hours after study PIVC is removed.
measure: Clinician reported experience measures of the dressing including application and removal
timeFrame: Daily until 48hours after study PIVC is removed.
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Queensland
city: Poitiers
country: France
facility: University Hospital of Poitiers
state: Nouvelle-Aquitaine
Study officials:
affiliation: The University of Queensland
name: Claire Rickard
role: PRINCIPAL_INVESTIGATOR
References: