Randomised controlled trial of an integrated securement device or tissue adhesive versus standard care (bordered polyurethane) dressings on peripheral intravenous cannula failure in paediatric patients.

Paediatric Reduction in Emergency Cannula Accidental REmoval (PRECARE) Trial: Randomised controlled trial of an integrated securement device or tissue adhesive versus standard care (bordered polyurethane) dressings on peripheral intravenous cannula failure in paediatric patients.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001026112

Acronym

PRECARE Trial

Enrollment

390

Registered

2019-07-18

Start date

2020-02-11

Completion date

2022-06-01

Last updated

2022-01-31

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

Conditions

None listed

Brief summary

There is a 25% failure rate for peripheral intravenous catheters (PIVC) inserted for infants and children requiring treatment within the emergency department and during hospitalisation. Our trial aims to test if new advances in catheter securement, medical grade superglue and an integrated dressing securement product are effective at preventing cannula failure and complications in paediatric patients. The outcome we are measuring is the decrease in failure rate between standard treatment and our new securement devices.

Interventions

Participants in this study will have a Peripheral Intravenous Cannula (PIVC) inserted in the emergency department by paediatric specialised Doctors and Nurses. Consented patients will have their PIVC dressed and secured with one of the three following randomly assigned options: 1) Standard care (CONTROL): Bordered polyurethane dressing (BPU) (Tegaderm Advanced®; 3M) – standard care most commonly used at Logan and Ipswich hospital Emergency Department 2) Advanced dressing: SorbaView SHIELD® (Centurion Medical Products) 3) Advanced dressing with tissue adhesive: SorbaView SHIELD® (Centurion Medical Products) and Tissue Adhesive (SecurePortIV™ (Adhezion Biomedical®) Patients will be monitored daily for a maximum of 4 weeks to ensure protocol adherence and assess for any complications. The randomly allocated dressing will be applied from device insertion and changed as clinically indicated until removal of the PIVC.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Investigator)

Eligibility

Sex/Gender

All

Age

6 Months to 8 Years

Healthy volunteers

Inclusion criteria

• Aged greater than 6 months to 8 years inclusive • Anticipated requirement for a PIVC for more than 24hours • Hospital admission to the inpatient unit requiring an expected stay of 24 hours or more

Exclusion criteria

• Known allergy to study products • Non-English-speaking family without interpreters • Has a currently identified blood stream infection • Current skin tear or at high risk of tear • Previous participation in the study

Outcome results