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CLEAN3 - first-of-its-kind randomized clinical trial published in The Lancet Infectious Diseases.- BD (Becton, Dickinson and Company)

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Published:22nd Feb 2021
BD (Becton, Dickinson and Company) , a leading global medical technology company, announced that new clinical data has 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 trial, published in the [January] edition of 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). The CLEAN3 trial also evaluated skin antiseptics with 2% chlorhexidine-gluconate (CHG) 70% isopropyl alcohol (IPA) single use, sterile applicator (BD ChloraPrep), 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 peripheral IV catheters, 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, and the PIVCs were continuously infused with saline or polyionic solution, by gravity. PIVCs ( peripheral intravenous catheters ) are the most commonly used invasive medical devices in hospitals, where about 2 billion are placed annually worldwide.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, dislodgement and infiltration. This can lead to longer hospital stays, higher inpatient costs, and great risk of death than patients without these preventable complications. In addition, unnecessary PIVC replacement can be painful to patients and lead to additional costs, 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. See- Guenezan J, Drugeon B, O’Neill R, et al." Skin antisepsis with chlorhexidine-alcohol versus with povidone iodine-alcohol, combined or not with a combination of innovative solutions, for prevention of short-term peripheral venous-catheter infection and failure: an investigator-initiated, open label, single centre, randomized, two by two factorial trial-CLEAN 3 study". Lancet Infectious Disease 2021. doi: 10.1016/S1473-3099(20)30738-6.
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Type: drug

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