- There is robust evidence that the BD vascular care
solution and skin antiseptic for peripheral intravenous catheters
used in the CLEAN3 randomized clinical trial can help improve
patient outcomes
- Compared with standard approaches, the BD vascular care
solution reduced the relative risk of catheter failure by 27%,
resulting in longer catheter dwell time without complications
- The use of 2% CHG 70% IPA single use, sterile applicator skin
antiseptic reduced the risk of infectious complications (catheter
colonization and local infection) by 92% compared with 5% povidone
iodine (PVI) 69% ethanol
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
- 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.
- Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted
but unacceptable: peripheral IV catheter failure. J Infus
Nurs 2015; 38: 189–203.
- 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.
- 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.
- 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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