2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial

Catheter-related sepsis (CRS) is a major complication with significant morbidity and mortality. Evidence is lacking regarding the most appropriate antiseptic for skin disinfection before percutaneous central venous catheter (PCVC) insertion in preterm neonates. To inform the feasibility and design of a definitive randomised controlled trial (RCT) of two antiseptic formulations, the authors conducted the Antiseptic Randomised Controlled Trial for Insertion of Catheters (ARCTIC) feasibility study to assess catheter colonisation, sepsis, and skin morbidity.
Their conclusion: the data from the ARCTIC study suggest that both 2% CHG-aqueous solution and 2% CHG-70% IPA can be used safely in preterm neonates when applied using a strict procedure to limit overexposure. Their use was associated with a large reduction in the risk of catheter colonisation by potentially harmful bacteria compared with historical rates using weaker preparations. A definitive trial is feasible, but based on the very low catheter colonisation rate or combined rate of CRS and CAS, a very large sample size is required. Newer agents such as octenidine now require formal evaluation in preterm neonates. But with such low rates of catheter colonisation and sepsis, conducting any definitive efficacy RCT of antiseptics now poses a formidable challenge. Other ways to distinguish between disinfection agents may be needed, such as registry or real-world data-based assessments of safety and efficacy, or else snapshot audits involving a limited number of centres willing to adopt uniform strict protocols and standardised procedures for catheter care and sampling.

Authors :

Paul Clarke ^{1 2}, Aung Soe ³, Amy Nichols ⁴, Helen Harizaj ³, Mark A Webber ^{2 5}, Louise Linsell ⁶, Jennifer L Bell ⁶, Catherine Tremlett ⁷, Priyadarsini Muthukumar ⁴, Santosh Pattnayak ³, Christopher Partlett ⁶, Andrew King ⁶, Ed Juszczak ⁶, Paul T Heath ⁸

• 1 Neonatal Intensive Care Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, Norfolk, UK paul.clarke@nnuh.nhs.uk
• 2 Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK.
• 3 Neonatal Intensive Care Unit, Medway Maritime Hospital, Gillingham, Kent, UK.
• 4 Neonatal Intensive Care Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, Norfolk, UK.
• 5 Quadram Institute Bioscience, Norwich, Norfolk, UK.
• 6 National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
• 7 Department of Microbiology, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, Norfolk, UK.
• 8 Centre for Neonatal and Paediatric Infection, Infection and Immunity, Saint George’s University of London, London, UK.
• Correspondence to
  Professor Paul Clarke, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, Norfolk, UK; paul.clarke@nnuh.nhs.uk

Clarke P, Soe A, Nichols A, et al. Arch Dis Child Fetal Neonatal Ed

• PMID: 37907266
• DOI: 10.1136/archdischild-2023-325871