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document
Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol , with and without skin scrubbing , for prevention of intravascular-catheter-related infection ( CLEAN ) : an open-label , multicentre , randomised , controlled , two-by-two factorial trial . BACKGROUND Intravascular-catheter-related infections are frequent life-threatening events in health care , but incidence can be decreased by improvements in the quality of care . Optimisation of skin antisepsis is essential to prevent short-term catheter-related infections . We hypothesised that chlorhexidine-alcohol would be more effective than povidone iodine-alcohol as a skin antiseptic to prevent intravascular-catheter-related infections . METHODS In this open-label , randomised controlled trial with a two-by-two factorial design , we enrolled consecutive adults ( age ≥18 years ) admitted to one of 11 French intensive-care units and requiring at least one of central-venous , haemodialysis , or arterial catheters . Before catheter insertion , we randomly assigned ( 1:1:1:1 ) patients via a secure web-based random-number generator ( permuted blocks of eight , stratified by centre ) to have all intravascular catheters prepared with 2 % chlorhexidine-70 % isopropyl alcohol ( chlorhexidine-alcohol ) or 5 % povidone iodine-69 % ethanol ( povidone iodine-alcohol ) , with or without scrubbing of the skin with detergent before antiseptic application . Physicians and nurses were not masked to group assignment but microbiologists and outcome assessors were . The primary outcome was the incidence of catheter-related infections with chlorhexidine-alcohol versus povidone iodine-alcohol in the intention-to-treat population . This study is registered with ClinicalTrials.gov , number NCT01629550 and is closed to new participants . FINDINGS Between Oct 26 , 2012 , and Feb 12 , 2014 , 2546 patients were eligible to participate in the study . We randomly assigned 1181 patients ( 2547 catheters ) to chlorhexidine-alcohol ( 594 patients with scrubbing , 587 without ) and 1168 ( 2612 catheters ) to povidone iodine-alcohol ( 580 patients with scrubbing , 588 without ) . Chlorhexidine-alcohol was associated with lower incidence of catheter-related infections ( 0·28 vs 1·77 per 1000 catheter-days with povidone iodine-alcohol ; hazard ratio 0·15 , 95 % CI 0·05-0·41 ; p=0·0002 ) . Scrubbing was not associated with a significant difference in catheter colonisation ( p=0·3877 ) . No systemic adverse events were reported , but severe skin reactions occurred more frequently in those assigned to chlorhexidine-alcohol ( 27 [ 3 % ] patients vs seven [ 1 % ] with povidone iodine-alcohol ; p=0·0017 ) and led to chlorhexidine discontinuation in two patients . INTERPRETATION For skin antisepsis , chlorhexidine-alcohol provides greater protection against short-term catheter-related infections than does povidone iodine-alcohol and should be included in all bundles for prevention of intravascular catheter-related infections . FUNDING University Hospital of Poitiers , CareFusion .
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Intervention_Pharmacological
chlorhexidine-alcohol
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Intervention_Pharmacological
povidone iodine-alcohol
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Intervention_Pharmacological
chlorhexidine-alcohol
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Intervention_Pharmacological
povidone iodine-alcohol
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Outcome_Adverse-effects
incidence of catheter-related infections
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Outcome_Adverse-effects
incidence of catheter-related infections
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Outcome_Adverse-effects
systemic adverse
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Participant_Condition
intravascular-catheter-related infection
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Participant_Age
adults
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Participant_Age
age ≥18 years )
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Participant_Condition
central-venous , haemodialysis , or arterial catheters
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Participant_Sample-size
2546 patients
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Participant_Sample-size
1181 patients
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Participant_Sample-size
2547 catheters