title: Efficacy of two antiseptic regimens on skin colonization of insertion sites for two different catheter types: a randomized, clinical trial.
abstract: OBJECTIVE
  Catheter-related bloodstream infections affect patients in surgical and intensive care settings worldwide, causing complications, aggravation of existing symptoms and increased length of stay. The trial aimed at comparing two registered skin antiseptics with respect to their residual and therefore infection-preventing effects.
  
  
  METHODS
  In a parallel, monocentric, prospective, triple-blind, randomized trial the difference in bacterial recolonization of catheter skin sites in central venous (CVC) and epidural catheters (EC) was investigated by comparing two alcoholic-based skin disinfectants. Patients receiving planned surgeries or intensive care were eligible for the trial. Those in the trial group received skin disinfection with the additive octenidine dihydrochloride (OCT) (n = 51), those in the control group were treated with benzalkonium chloride as additive (BAC) (n = 59) prior to catheter insertion. Randomization was carried out by assigning patients to groups week-wise. Endpoints of the investigation were skin colonization of the catheter site counted in colony forming units per swab at three time points: (1) prior to catheter insertion, on untreated skin; (2) directly after catheter insertion, prior to sterile coverage; (3) 48 h after catheter insertion. The hypothesis was tested by a Wilcoxon test with a two-sided alpha = 5 %.
  
  
  RESULTS
  From second to third swab, recolonization of the catheter-surrounding skin was significantly lower in the trial group for both sorts of catheters: delta 2-3 OCT group: 0.72 (95 % CI: 0.42; 1.02); delta 2-3 BAC group: 1.97 (95 % CI: 1.45; 2.50); p < 0.001. None of the patients enrolled developed a catheter-related blood stream infection (CRBSI) during follow-up.
  
  
  CONCLUSIONS
  Previous studies have shown that skin colonization is strongly associated with the occurrence of CRBSI. This randomized controlled trial supports the observations made in previous trials that octenidine dihydrochloride in disinfectants is more effective than agents containing other additives with regard to skin recolonization surrounding CVC and EC insertion sites. Therefore, it is likely to also reduce the risk of CRBSI in these patient groups. The trial was approved by the North Rhine Medical Association in July 2014 (application-no.: 2014222).
authors.affiliation: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, St. Vinzenz-Hospital, Merheimer Str. 221-223, 50733, Cologne, Germany. juergen.lutz@cellitinnen.de.
authors.forename: Juergen Thomas
authors.initials: JT
authors.lastname: Lutz
authors.affiliation: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, St. Vinzenz-Hospital, Merheimer Str. 221-223, 50733, Cologne, Germany.
authors.forename: Isabel Victoria
authors.initials: IV
authors.lastname: Diener
authors.affiliation: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, St. Vinzenz-Hospital, Merheimer Str. 221-223, 50733, Cologne, Germany.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Freiberg
authors.affiliation: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, St. Vinzenz-Hospital, Merheimer Str. 221-223, 50733, Cologne, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Zillmann
authors.affiliation: Institute of Medical Statistics, Informatics and Epidemiology, University Hospital of Cologne, Gleueler Str. 46, 50931, Cologne, Germany.
authors.forename: Kija
authors.initials: K
authors.lastname: Shah-Hosseini
authors.affiliation: Institute for Medical Microbiology, Immunology and Hygiene, University of Cologne, Goldenfelsstr. 19-21, 50935, Cologne, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Seifert
authors.affiliation: Laboratory Dr. Wisplinghoff, Classen-Kappelmann-Str. 24, 50931, Cologne, Germany.
authors.forename: Bettina
authors.initials: B
authors.lastname: Berger-Schreck
authors.affiliation: Institute for Medical Microbiology, Immunology and Hygiene, University of Cologne, Goldenfelsstr. 19-21, 50935, Cologne, Germany.|Laboratory Dr. Wisplinghoff, Classen-Kappelmann-Str. 24, 50931, Cologne, Germany.
authors.forename: Hilmar
authors.initials: H
authors.lastname: Wisplinghoff
mesh_terms: D000891:Anti-Infective Agents, Local / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D055499:Catheter-Related Infections / Q000188:drug therapy / Q000517:prevention & control*; D002405:Catheterization, Central Venous / Q000009:adverse effects*; D062905:Central Venous Catheters; D015169:Colony Count, Microbial; D004203:Disinfection / Q000379:methods / Q000706:statistics & numerical data; D006801:Humans; D011446:Prospective Studies; D012867:Skin / Q000187:drug effects / Q000382:microbiology
chemical_list: D000891:Anti-Infective Agents, Local
keywords: Alcoholic disinfection; Bacterial recolonization; Benzalkonium chloride; Catheter-related bloodstream infection; Central venous catheter; Epidural catheter; Octenidine dihydrochloride