Skin antisepsis with chlorhexidine–alcohol versus povidone iodine–alcohol, combined or not with use of a bundle of new devices, for prevention of short-term peripheral venous catheter-related infectious complications and catheter failure: an open-label, single-centre, randomised, four-parallel group, two-by-two factorial trial: CLEAN 3 protocol study

Abstract

IntroductionShort peripheral intravenous catheters (PVCs) are the most frequently used invasive medical devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the occurrence of mechanical, vascular or infectious complications, which prolongs hospitalisation and increases healthcare costs and mortality.Prevention of these complications is mainly based on the respect of hygiene rules and the use of biocompatible catheters. In critically ill patients, 2% chlorhexidine-alcohol is superior to 5% povidone iodine-alcohol for skin preparation before central venous and arterial catheters; whether this finding can be extended to PVC inserted in the wards remains speculative. Similarly, the use of new technologies such as catheters designed to minimise blood exposure, zero-reflux needleless connectors, disinfecting caps and flushing PVCs before and after each medication administration to maintain catheter patency are of theoretical interest to prevent PVC failure, but little scientific data support their routine use.Methods and analysisThe CLEAN 3 study is an open-label, single-centre, randomised, two-by-two factorial trial. One thousand patients visiting our emergency department and requiring hospital admission in the wards will be randomised to one of four strategies according to skin preparation and devices used. The two primary endpoints will be (1) the incidence of infectious complications related to the catheters (colonisation, local infection or bloodstream infection) and (2) the time between catheter insertion and catheter failure defined as any premature removal of PVC before end of treatment, other than for routine replacement.Ethics and disseminationThis protocol has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registration numberEudraCT 2018-A02535-50; NCT03757143.

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“…Alcohols proved to be useful in superficial disinfection of non-critical and semi-critical equipment (stethoscopes, pagers, cell phones), in wiping the surfaces of ampoules and vials [ 4 ]. Wiping the openings of vascular catheters with swabs impregnated with chlorhexidine alcohol solution and the use of ports containing 70% isopropyl alcohol are part of the strategy to reduce the risk of catheter-related infections [ 5 , 6 ]. It is also recommended to rinse the working canals of endoscopes with a 70–90% solution of ethyl or isopropyl alcohol after high-degree disinfection [ 5 , 6 ].…”

“…Wiping the openings of vascular catheters with swabs impregnated with chlorhexidine alcohol solution and the use of ports containing 70% isopropyl alcohol are part of the strategy to reduce the risk of catheter-related infections [ 5 , 6 ]. It is also recommended to rinse the working canals of endoscopes with a 70–90% solution of ethyl or isopropyl alcohol after high-degree disinfection [ 5 , 6 ]. The disadvantages of alcohols are their flammability, lower efficiency in the presence of organic pollutants and quick evaporation.…”

“…Rapid evaporation makes them ineffective in disinfecting large surfaces on which pathogenic microorganisms can accumulate. Bacteria that accompany us throughout our lives, gaining resistance to drugs and attacking a weakened organism, has become a lethal threat [ 5 , 6 ]. Unfortunately, losing antibiotics and disinfectants as an effective weapon against increasingly resistant strains of bacteria, we must reach for newer and stronger compounds that will be more toxic to microorganisms, and their molecules can be used as sprayers for cleaning surfaces and hands.…”

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

“…The study protocol was approved by the French Southwest and Overseas Ethics Committee and the French Drug Safety Agency, and was published elsewhere. 13 The study was carried out in accordance with the principles of the Declaration of Helsinki and the Clinical Trials Directive 2001/20/EC and 2005/28/EC of the European Parliament.…”

Routine replacement versus replacement as clinical indicated of peripheral intravenous catheters: A multisite randomised controlled trial

“…All‐cause BSI is defined as any positive blood culture drawn from a peripheral vein while the PIVC is in situ or 48 hours after removal. Local infection means that there are organisms grown from purulent discharge with no evidence of associated bloodstream infection (Guenezan et al, 2019; Webster et al, 2019).…”