Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)

NCT05741866 | Unknown DMC FDA Device

• 1 other identifier: 2022/HE001952
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (2)

• Feasibility for a definitive RCT

  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

  On completion of 300 participants

• Catheter-related infectious complications and phlebitis

  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.

  Daily until 48hours after study PIVC is removed.

Secondary Outcomes (12)

• PIVC tip colonization

  Daily until 48hours after study PIVC is removed.

• PIVC local infection without Bloodstream Infection (BSI)

  Daily until 48hours after study PIVC is removed.

• PIVC-associated Bloodstream Infection

  Daily until 48hours after study PIVC is removed.

• Phlebitis

  Daily until 48hours after study PIVC is removed.

• PIVC device failure

  Daily until 48hours after study PIVC is removed.

Study Arms (2)

Control

ACTIVE COMPARATOR

Bordered Polyurethane Dressing

Device: Standard bordered polyurethane dressing

Intervention

EXPERIMENTAL

CHG Bordered Polyurethane Dressing

Device: Chlorhexidine gluconate impregnated bordered polyurethane dressing

Interventions

Chlorhexidine gluconate impregnated bordered polyurethane dressing DEVICE

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.

Also known as: Tegaderm™ Antimicrobial I.V. Advanced Securement (9132)

Intervention

Standard bordered polyurethane dressing DEVICE

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.

Also known as: Tegaderm™ IV Advanced (1682 or 1683)

Control

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Queensland: lead
• Queensland Children's Hospital: collaborator
• Royal Brisbane and Women's Hospital: collaborator
• University Hospital of Poitiers: collaborator
• Griffith University: collaborator

Study Sites (3)

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

RECRUITING

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

RECRUITING

University Hospital of Poitiers

Poitiers, Nouvelle-Aquitaine, 86000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 39013653 DERIVED

MeSH Terms

Conditions

Prosthesis-Related Infections; Catheter-Related Infections; Wound Infection; Wounds and Injuries; Phlebitis

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Officials

• Claire Rickard

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ProP - Project Manager

CONTACT

+61 (0) 7 36467671; catherine.obrien2@health.qld.gov.au

Daner Ball

CONTACT

+61 (7) 3346 6077; d.ball@uq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, blinding of patients/clinicians to the intervention is not possible. However, the statistician will be blinded for analysis; and the microbiologist and laboratory staff will also be blinded to treatment allocation when apportioning infection outcomes. 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multi-centre, two-arm, parallel group adaptive randomised controlled trial

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: February 23, 2023
• Study Start: May 3, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 21, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); FR (1)