Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) (ProP)

The University of Queensland

Status: Enrolling

Conditions: Device Related Infection; Occlusive Dressings; Wound of Skin; Catheter Complications; Wound Infection; Device Related Sepsis; Wound; Vascular Access Complication; Catheter Related Complication; Catheter-Related Infections; Catheter Infection; Device Site Reactions

Treatments: Device: Standard bordered polyurethane dressing; Device: Chlorhexidine gluconate impregnated bordered polyurethane dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT05741866

2022/HE001952

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Control

Active Comparator group

Description:

Bordered Polyurethane Dressing

Treatment:

Device: Standard bordered polyurethane dressing

Intervention

Experimental group

Description:

CHG Bordered Polyurethane Dressing

Treatment:

Device: Chlorhexidine gluconate impregnated bordered polyurethane dressing