Evaluating methods for effective decontamination of central venous access devices needleless connectors in adult hospital patients: A pilot randomised control trial protocol

Evaluating methods for effective decontamination of central
venous access devices needleless connectors in adult hospital patients: A pilot randomised control trial protocol

Background: The importance of decontaminating needleless connectors prior to accessing central venous access devices (CVADs) to prevent CVAD-associated bloodstream infection has been highlighted. However, the optimal decontamination time and solution is still under-evaluated. Aim: This study will compare different decontamination methods of CVAD needleless connectors in adult patients. The aims of this pilot trial are: to assess recruitment feasibility, data collection strategies and proposed methods; and to test the interventions with the control to determine an adequate sample size for a future, larger clinical trial. Design: A single-centre, parallel, pilot randomised control trial (RCT) with a superiority design. Methods: There will be three arms: 70% isopropyl alcohol swab (control);2.0% chlorhexidine gluconate in 70% isopropyl alcohol swab; and a 70%isopropyl alcohol-impregnated cap. The primary outcome of this pilot trial is to assess feasibility for a future, larger clinical trial. The secondary outcome is CVAD-associated bloodstream infection. In total, 120 patients will be recruited over six months with a four-week follow-up. Prospective patients who are scheduled to have a CVAD inserted will be eligible. Randomisation will be computer-generated, central and concealed until allocation. Due to the nature of the interventions it will not be possible to blind clinicians or patients. Discussion: Preventing CVAD-associated bloodstream infection in hospitalised patients is vital. Interventional decontamination techniques that demonstrate superior performance in preventing CVAD-associated bloodstream infection would improve patient outcomes, reduce patient morbidity and mortality, and health care-associated costs.