First-of-its-Kind Randomized Clinical Trial Published in "The Lancet Infectious Diseases" Outlines Potential New Standard-Setting Best Practices for Peripheral IV Catheters

Rhea-AI Summary

BD (Becton, Dickinson and Company) announced positive outcomes from the CLEAN3 trial, demonstrating that its vascular care solution significantly reduces peripheral intravenous catheter (PIVC) failures, showing rates of 34.8% versus 47.5% in the control group. The trial observed enhanced performance regarding antiseptics, with catheter colonization at 0.9% compared to 16.9%. Conducted at Poitiers University Hospital, France, the study involved around 1,000 patients, highlighting the benefits of BD’s integrated solution for improving patient safety and reducing hospital costs.

Positive

• CLEAN3 trial showed 34.8% PIVC failure rate with BD solution versus 47.5% in control.
• Median time to PIVC failure extended to 50.4 hours with BD's solution compared to 30.0 hours.
• Catheter colonization reduced to 0.9% with 2% CHG-70% IPA antiseptic, versus 16.9% for 5% PVI-69% ethanol.

Negative

• None.

FRANKLIN LAKES, N.J., Feb. 2, 2021 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that new clinical data have found robust evidence that using a vascular care solution can help improve outcomes for patients requiring peripheral intravenous catheters (PIVCs).

The results of the CLEAN3 trial¹, published in The Lancet Infectious Diseases, showed the use of the BD vascular care solution resulted in fewer PIVC failures compared with the standard group (34.8% vs. 47.5%, respectively) and extended the median time between catheter insertion and failure (50.4 hours vs 30.0 hours, respectively). PIVC failure was defined as any premature removal of PIVC before end of treatment – other than for routine replacement – and included phlebitis, infiltration, occlusion, dislodgment, local infection and catheter-related bloodstream infection (whichever occurred first).

The CLEAN3 trial also evaluated skin antiseptics with 2% chlorhexidine-gluconate (CHG) 70% isopropyl alcohol (IPA) single use, sterile applicator versus 5% povidone iodine (PVI) 69% ethanol applied with sterile gauze in preventing infectious complications related to the use of PIVCs (catheter colonization: 0.9% vs. 16.9%, respectively; local infection: 0% vs. 1.2%, respectively). 

The trial, which involved approximately 1,000 patients from nine different medical wards within a single university hospital (Poitiers University Hospital, France), evaluated PIVC failure rates by comparing the BD vascular care solution for PIVCs, which included an integrated PIVC (BD Nexiva™), a positive displacement needle-free connector (BD MaxZero™), a disinfecting cap (BD PureHub™) and a sterile prefilled flush syringe (BD PosiFlush™) – compared with a standard group, which included a straight safety PIVC (BD Insyte™ Autoguard™ BC Winged), extension set three-way stopcock; the PIVCs were continuously infused with saline or polyionic solution, by gravity.

"The findings of the CLEAN3 trial support the use of an integrated solution as the best practice standard when peripheral IV catheter dwell time is expected to exceed 24 hours," said Professor Olivier Mimoz, head of the emergency department at Poitiers University Hospital, France, and principal investigator of the CLEAN3 trial. "Furthermore, the study shows that the use of 2% CHG-70% IPA single use, sterile applicator should become the first-line antiseptic for skin disinfection prior to PIVC insertion. We believe that the results can be extrapolated to all adult patients admitted to a medical ward requiring a PIVC placement and, by extrapolation, to those admitted to a surgical ward."

PIVCs are the most commonly used invasive medical devices in hospitals, where about 2 billion are placed annually worldwide.^2,3 However, in hospitals, 35% to 50% of PIVCs do not meet their intended dwell time and need to be removed prematurely due to preventable complications, such as infection, occlusion, phlebitis, dislodgment and infiltration.² This can lead to longer hospital stays, higher inpatient costs, and greater risk of death than in patients without these preventable complications.⁴ In addition, unnecessary PIVC replacement can be painful to patients and lead to additional costs,⁵ as well as have an effect on health care professionals' ability to support other patients. Bloodstream infections can have an even greater impact, by prolonging hospitalization and increasing treatment costs and mortality.⁴  

"Despite the extensive use of PIVCs in hospitals and the frequency and severity of complications that can be associated with them, CLEAN3 is the first large-scale, randomized clinical trial of its kind, looking at an integrated solution to prevent complications leading to catheter failure and assessing the efficacy of two skin antiseptics in preventing catheter-related complications," said Dr. Klaus Hoerauf, vice president, global medical affairs, Medication Delivery Solutions for BD. "The BD vascular care solution for peripheral IV catheters and skin antiseptic that were found to be efficacious in this trial are part of our integrated approach to help clinicians reduce complications and improve patient safety and care."    

View the study publication in The Lancet Infectious Diseases here: http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30738-6/fulltext.

About BD 
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com. 

This was an investigator-sponsored study (Poitiers University Hospital, France) supported by Becton Dickinson (BD). BD had no role in trial initiation, study design, choice of antiseptic products, data collection, data analysis, data interpretation, writing of the report, or the decision to submit. The authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

BD, the BD Logo, Insyte Autoguard, MaxZero, Nexiva, PosiFlush and PureHub are trademarks of Becton, Dickinson and Company or its affiliates.
© 2021 BD. All rights reserved.
BD PureHub™ – BD Nexiva™ – BD Insyte™ Autoguard™ – BD MaxZero™ – BD PosiFlush™

These medical devices are CE marked and are CE certified by BSI Group The Netherlands B.V.   

Product indications and registrations may vary by country and regions.

Contacts:  
Troy Kirkpatrick  
BD Public Relations 
858.617.2361 
troy.kirkpatrick@bd.com  

Kristen M. Stewart, CFA 
BD Investor Relations 
845.642.1256 
Kristen.Stewart@bd.com 

References

1. Guenezan J, Marjanovic N, Drugeon B, O Neill R, Liuu E, Roblot F, Palazzo P, Bironneau V, Prevost F, Paul J, Pichon M, Boisson M, Frasca D, Mimoz O. Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial. Lancet Infect Dis 2021. Published online February 1, 2021. 
2. Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs 2015; 38: 189–203.
3. Rickard CM, Marsh N, Webster J, et al. Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomized controlled, superiority trial. Lancet 2018; 392: 419–30.
4. Lim S, Gangoli G, Adams E, et al. Increased clinical and economic burden associated with peripheral intravenous catheter-related complications: Analysis of a US hospital discharge database. Inquiry 2019; 56: 46958019875562.
5. Tuffaha HW, Rickard CM, Webster J, et al. Cost-effectiveness analysis of clinically indicated versus routine replacement of peripheral intravenous catheters. Appl Health Econ Health Policy 2014; 12: 51–8.

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SOURCE BD (Becton, Dickinson and Company)

FAQ

What were the results of the CLEAN3 trial for BDX?

The CLEAN3 trial found that BD's vascular care solution reduced PIVC failures to 34.8% compared to 47.5% in the control group.

How does the BD vascular care solution improve PIVC performance?

The BD vascular care solution extends the median time between catheter insertion and failure significantly, improving patient outcomes.

What antiseptic was recommended in the CLEAN3 trial?

The trial concluded that 2% chlorhexidine-gluconate combined with 70% isopropyl alcohol should be the first-line antiseptic for skin disinfection prior to PIVC insertion.

How many patients were involved in the CLEAN3 trial?

The CLEAN3 trial involved approximately 1,000 patients at Poitiers University Hospital in France.

What is the significance of the CLEAN3 trial's findings for BDX?

The findings support BD's vascular care solution as a potential standard practice, which could enhance its market position and clinical adoption.