Randomized controlled trial on healthy volunteers of pharmacokinetic and antimicrobial activity of a novel hydrogel-containing chlorhexidine dressing to prevent catheter-related bloodstream infection.

Emili Masferrer, Laura Riera-Rodríguez, Víctor Farré-Alins, Sandra Vilà de Muga, Francisco-Javier Arroyo-Muñoz, María-Dolores González-Caro
Author Information
  1. Emili Masferrer: Department of Dermatology, Hospital Universitari Mútua Terrassa, Terrassa, Spain.
  2. Laura Riera-Rodríguez: Department of Dermatology, Hospital Universitari Mútua Terrassa, Terrassa, Spain.
  3. Víctor Farré-Alins: Iberhospitex, S.A., Barcelona, Spain.
  4. Sandra Vilà de Muga: Iberhospitex, S.A., Barcelona, Spain.
  5. Francisco-Javier Arroyo-Muñoz: Intensive Care Unit, Hospital Universitario Virgen Macarena, Sevilla, Spain.
  6. María-Dolores González-Caro: Intensive Care Unit, Hospital Universitario Virgen Macarena, Sevilla, Spain.

Abstract

Introduction: Catheter-related blood stream infection (CRBSI) is one of the most relevant complications associated to the use of intravascular catheters. In this context, chlorhexidine gluconate (CHG) releasing dressings have been developed to reduce the catheter colonization rate and the risk of infection. The aim of this study is to analyze the release rate of CHG and the antimicrobial activity of a novel CHG-releasing dressing, Oper film protect CHG, and to compare these parameters to those of the dressing Tegaderm™ CHG in healthy volunteers.
Methods: The study was performed in a cohort of 25 healthy volunteers. Two commercially available chlorhexidine-containing dressings were evaluated and compared in this study, Oper film protect CHG and Tegaderm™ CHG. The release of CHG and the antimicrobial capacity was determined for one week.
Results: HPLC analysis revealed that both dressings have an equivalent CHG release to the skin 2 days (Oper film protect CHG, 321 μg/cm; Tegaderm™ CHG, 279 μg/cm) and 7 days (Oper film protect CHG, 456 μg/cm; Tegaderm™ CHG, 381 μg/cm) after the placement of the products in the non-disinfected back of the subjects. On the other hand, Oper film protect CHG and Tegaderm™ CHG similarly reduced colony forming units (CFU) in cultures obtained from the skin under the CHG-containing hydrogel compared to control cultures at both 2 days (control, 3.34 log cfu/cm; Oper film protect CHG, 0.64 log cfu/cm; Tegaderm™ CHG, 0.7 log cfu/cm) and 7 days (control, 3.95 log cfu/cm; Oper film protect CHG, 0.11 log cfu/cm; Tegaderm™ CHG, 1 log cfu/cm).
Discussion: Data confirm that the recent commercially available dressing Oper film protect CHG maintains the release of CHG and the antimicrobial activity during at least 7 days, and possesses equivalent drug release and antimicrobial action to Tegaderm™ CHG.

Keywords

References

  1. Antimicrob Agents Chemother. 2008 Oct;52(10):3633-6 [PMID: 18676882]
  2. Dermatitis. 2013 May-Jun;24(3):112-8 [PMID: 23665831]
  3. J Antimicrob Chemother. 2014 Aug;69(8):2224-9 [PMID: 24722839]
  4. Curr Res Immunol. 2023 Mar 28;4:100057 [PMID: 37025390]
  5. Pediatrics. 2001 Jun;107(6):1431-6 [PMID: 11389271]
  6. Antibiotics (Basel). 2023 Apr 22;12(5): [PMID: 37237701]
  7. Crit Care. 2005;9(6):R631-5 [PMID: 16280064]
  8. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46 [PMID: 23999949]
  9. Crit Care Med. 2014 Jul;42(7):1703-13 [PMID: 24674924]
  10. Anesthesiology. 1990 Oct;73(4):625-31 [PMID: 2121070]
  11. Lancet Infect Dis. 2011 Jan;11(1):30-8 [PMID: 21126917]
  12. PLoS One. 2021 Aug 19;16(8):e0256336 [PMID: 34411140]
  13. J Hosp Infect. 2005 Sep;61(1):53-61 [PMID: 16002181]
  14. Crit Care. 2020 Jul 23;24(1):458 [PMID: 32703235]
  15. BMC Infect Dis. 2019 May 16;19(1):429 [PMID: 31096918]
  16. Curr Res Microb Sci. 2022 Nov 17;3:100175 [PMID: 36518176]
  17. JAMA. 2009 Mar 25;301(12):1231-41 [PMID: 19318651]
  18. Infection. 2015 Feb;43(1):29-36 [PMID: 25331552]
  19. Infect Control Hosp Epidemiol. 2020 Dec;41(12):1388-1395 [PMID: 32935659]
  20. J Perinatol. 2013 Oct;33(10):768-71 [PMID: 23702618]
  21. Am J Infect Control. 2012 May;40(4):344-8 [PMID: 21737178]

Word Cloud

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