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Efficacy of two antiseptic regimens on skin colonization of insertion sites for two different catheter types: a randomized, clinical trial

View Article: PubMed Central - PubMed

ABSTRACT

Purpose: 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).

No MeSH data available.


Colony forming units at the insertion sites of catheters. CFUs/swab are displayed before, immediately after and 48 h after disinfection with Alcohol/BAC or Alcohol/OCT. Sites for CVC and EC are shown separately. Statistical analyses were carried out within and between groups (1 and 2)
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Fig2: Colony forming units at the insertion sites of catheters. CFUs/swab are displayed before, immediately after and 48 h after disinfection with Alcohol/BAC or Alcohol/OCT. Sites for CVC and EC are shown separately. Statistical analyses were carried out within and between groups (1 and 2)

Mentions: Side effects such as redness, swelling or pathological serum parameters were mild, rare and occurred in all groups. Few patients in all groups developed slight redness (n = 7, trial: n = 3; control: n = 4) or swelling (n = 3; trial: n = 2; control: n = 1) around the catheter insertion site (see Fig. 2; Table 1).Fig. 2


Efficacy of two antiseptic regimens on skin colonization of insertion sites for two different catheter types: a randomized, clinical trial
Colony forming units at the insertion sites of catheters. CFUs/swab are displayed before, immediately after and 48 h after disinfection with Alcohol/BAC or Alcohol/OCT. Sites for CVC and EC are shown separately. Statistical analyses were carried out within and between groups (1 and 2)
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5121173&req=5

Fig2: Colony forming units at the insertion sites of catheters. CFUs/swab are displayed before, immediately after and 48 h after disinfection with Alcohol/BAC or Alcohol/OCT. Sites for CVC and EC are shown separately. Statistical analyses were carried out within and between groups (1 and 2)
Mentions: Side effects such as redness, swelling or pathological serum parameters were mild, rare and occurred in all groups. Few patients in all groups developed slight redness (n = 7, trial: n = 3; control: n = 4) or swelling (n = 3; trial: n = 2; control: n = 1) around the catheter insertion site (see Fig. 2; Table 1).Fig. 2

View Article: PubMed Central - PubMed

ABSTRACT

Purpose: 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).

No MeSH data available.