First-of-its-Kind Randomized Clinical Trial Published in "The Lancet Infectious Diseases" Outlines Potential New Standard-Setting Best Practices for Peripheral IV Catheters
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 (
"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
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.
View the study publication in The Lancet Infectious Diseases here: http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30738-6/fulltext.
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- 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.
Lancet2018; 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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