Comparing the effectiveness of PowerPICC(Trademark) with BioFlo(Trademark) on Peripherally-Inserted Central Catheter(PICC)-related Occlusion and Infection Rates in the Oncology/Haematology Setting: A Randomised Controlled Trial

Comparing the effectiveness of PowerPICC(Trademark) with BioFlo(Trademark) on PICC-related Occlusion and Infection Rates in the Oncology/Haematology Setting: A Randomised Controlled Trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001354471

Enrollment

240

Registered

2016-09-29

Start date

2016-10-03

Completion date

Unknown

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) are considered a conventional mode of treatment provision in most hospitals, and mostly favoured by patients and clinicians. However, the effectiveness of PICCs can be offset by complications, most commonly occlusion and bloodstream infections. As a result, PICC technology is advancing and designed to limit complications, hence the hospital currently uses PowerPICC(Trademark). Recently, a newer product BioFlo(Trademark) claims to have better technology, thus hypothesised to have better protection against occlusion and bloodstream infections. The proposed study aims to compare and evaluate the effectiveness two types of PICC lines – BioFlo(Trademark)and PowerPICC(Trademark) - on the incidence of bloodstream infections and the incidence of occlusions in a private haematology/oncology setting. It is anticipated that the results of this study will determine the product to be used across the Mater Misericordiae Limited Brisbane.

Interventions

Recently, BioFlo(Trademark) PICC (Angiodynamics) has become available and approved by the Therapeutic Good Administration. The technology enhancements include added Pressure Activated Safety Valve that is designed to resist back flow and reduce blood reflux on the inside of the catheter to mitigate occlusion or BSI. As well, the BioFlo(Trademark) has Endexo technology that makes the PICC more resistant to the accumulation of blood components particularly platelets and thrombus. Patients will be randomly allocated to this intervention. The PICC lines will be inserted in Radiology by a radiologist.. A research nurse will access patients' health record weekly (coincides with weekly dressing changes) to monitor for signs of complications including blockage and bloodstream infection from the date of insertion until PICC removal. The PICC will remain in situ until device failure or no longer required, at the discretion of the treating doctor. There is no maximum duration of PICC use for the purpose of this study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1 Adults (18 years old and over) 2 Patients referred to Queensland X-Ray Mater Private Hospital Brisbane who require a PICC line 3 Able to provide written consent or have access to a ‘person responsible’ and can provide the consent on behalf of the patient* 4 Able to speak and write English or have access to a medically-trained interpreter

Exclusion criteria

1 Patients younger than 18 years 2 Patients who are from a non-English speaking background and do not have access to a medically-trained interpreter 3 Patients who are unable to consent and do not have access to a ‘person responsible’

Outcome results