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Comparing peripherally inserted central catheter outcomes in adults; a pilot randomised controlled trial

Randomised controlled trial in adults of polyurethane PICC with endexo incorporated versus standard care polyurethane PICC to prevent PICC complication and failure

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001578493
Acronym
The PIC COMPARE trial
Enrollment
110
Registered
2016-11-16
Start date
2017-05-02
Completion date
2018-02-06
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Peripherally inserted central catheters (PICCs) were developed to provide short to medium term vascular access for patients requiring the infusion of vessel irritant medications, or frequent blood sampling. While PICC’s provide necessary, reliable and accessible vascular access; they are associated with biological, mechanical or infectious complication. These complications result in delayed treatment, need for reinsertion, and delayed treatment of the underlying complication - causing extended admission time, increased healthcare costs, venous depletion and increased morbidity and mortality. Microbial biofilm formation makes treatment of infections more complicated since the detached microbial cells from the biofilm can repeatedly infect the blood, and these microorganisms are highly resistant to many antimicrobial agents, frequently requiring PICC removal and antibiotic treatment. Maintaining catheter function is vital for the safe provision of treatment. BioFlo (trademark) PICC (by Angiondynamics; NY) claims to provide a novel solution and the manufacturers claim the material is resistant to blood products and biofilm development, reducing the risk of standard PICC complications including infection, fracture, thrombosis, leakage, localised swelling, accidental removal and dislodgement . These PICCs are now on the basis of some clinician preference at some Australian facilities. The effectiveness of this product at reducing PICC-associated complications as previously described has not been undertaken. We plan to undertake a randomized controlled trial at the RBWH. Patients who consent to participate in the trial will be randomly assigned to either study group. The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of this new PICC technology compared to older generation PICC relating to failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for adults with PICC in acute care.

Interventions

Patients in this study have peripherally inserted central catheters (PICC) inserted in the RBWH department of medical imaging. Consenting patients (if appropriate) will have the type of PICC inserted randomised to either one of the following randomly assigned products Arm 1: BioFlo polyurethane PICC with endexo technology Arm 2 (Control): Arrow polyurethane PICC The randomly allocated PICC will be inserted using standard technique for insertion and will remain insitu until completion of therap

Patients in this study have peripherally inserted central catheters (PICC) inserted in the RBWH department of medical imaging. Consenting patients (if appropriate) will have the type of PICC inserted randomised to either one of the following randomly assigned products Arm 1: BioFlo polyurethane PICC with endexo technology Arm 2 (Control): Arrow polyurethane PICC The randomly allocated PICC will be inserted using standard technique for insertion and will remain insitu until completion of therapy, or complication requiring removal. Patients will be followed until device removal, the maximum duration of follow up is 4 weeks.

Sponsors

Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Require PICC insertion at department of medical imaging for fluid or medication administration; Able to provide informed consent

Exclusion criteria

*non-tunnelled, tunnelled, dialysis or implanted CVADs or pulmonary artery catheters; *Current bloodstream infection *PICC to be inserted through diseased, burned or scarred skin'; *Allergy to study product; and *Previous study enrolment in this admission to hospita

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026