Peripherally Inserted Central catheter iNnovation to reduce Infections and Clots (the PICNIC trial): a randomised controlled trial protocol.

Peripherally inserted central catheters (PICCs) are vital for the delivery of medical therapies, but up to 30% of PICCs are associated with complications such as deep vein thrombosis or infection. The integration of antimicrobial and hydrophobic catheter materials, and pressure-activated valves, into polyurethane PICCs are innovations designed to prevent infective and/or thrombotic complications. A multicentre, parallel group, superiority randomised controlled trial with two experimental arms ((1) hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp)). Recruitment of 1098 adult and paediatric patients will take place over 2 years at three tertiary-referral hospitals in Queensland, Australia. Patients are eligible for inclusion if their PICC is to be inserted for medical treatment, with a vascular size sufficient to support a 4-Fr PICC or larger, and with informed consent. The primary outcome is Ethical approval from Queensland Health (HREC/QCHQ/48682) and Griffith University (Ref. No. 2019/094). Results will be published. ACTRN12619000022167.

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Competing interests: Griffith University (AJU's former employer) has received unrestricted research and educational grants to support her research (unrelated from the current project) from 3M, Becton Dickinson and Cardinal Health. Griffith University (DA’s employer) has received consultancy payments for educational lectures based on her research and clinical expertise from 3M and Johnsons and Johnsons. Griffith University (TK’s employer) has received unrestricted research and educational grants from 3M, Becton Dickinson and Medical Specialties Australasia. Griffith University (RMW’s employer) has received unrestricted research and educational grants to support her research (unrelated to current project) from Becton Dickinson. Griffith University (NMM's former employer) has received unrestricted research and educational grants to support her research (unrelated from the current project) from 3M, Becton Dickinson and Cardinal Health. Griffith University (AB's employer) has received consultancy payments from Becton Dickinson (unrelated to the current project). Griffith University (JB’s employer) has received unrestricted research and educational grants to support her research (unrelated to current project) from Becton Dickinson, and Navi Technologies. PM is a member of Myeloma Advisory Boards for Celgene, Janssen, Amgen, Takeda and Amyloidosis Advisory Boards for Pfizer and Caelum. No personal fees have been received for these services. PM’s has received a research grant from Janssen for a clinical trial. PM has accommodation and registration provided by Amgen for attendance at the International Myeloma Workshop in 2019. Griffith University (CMR's former employer) has received unrestricted research and educational grants to support her research (unrelated to the current project) from 3M, Becton Dickinson and Cardinal Health. Other authors have no conflicts of interests to disclose.