Table 2. Primary studies and systematic reviews evaluating chlorhexidine-containing antiseptics for the prevention of intravascular catheter-associated infections.
| Referencea | Study designb | Antiseptics comparedc | Outcomes catheter colonisationd | Outcomes CR-BSId | Comments | Attributione |
| Maki et al. 1991 [28] (C) | RCT; CVCs, ACs; insertion and maintenance | A: CHG aq 2%; B: PVI aq 10%; C: IPA 70% | A: 5/214; B: 21/227; C: 11/227; only A:B p<0.05 | A: 1/214; B: 6/227; C: 3/227; all NS | Seminal study; only arms A vs B in colonisation significant | Not applicable |
| Sheehan et al. 1993 [29] (C) | RCT; CVCs, ACs; insertion and maintenance | A: CHG aq 2%; B: PVI aq 10% | A: 3/169; B: 12/177; p<0.05 | A: 1/169; B: 1/177; NS | Conference abstract; colonisation significant | Not applicable |
| Garland et al. 1995 [30] | Non-RCT; PVCs; only insertion, not maintenancef | A: CHG 2% + IPA 70%; B: PVI aq 10% | A: 20/418; B: 38/408; p<0.05 | A: 2/418; B: 0/408; NS | Only colonisation significant | Incorrect |
| Meffre et al. 1996 [31] (C) | RCT; PVCs; insertion and maintenance | A: CHG 0.5% + ALC (?%); B: PVI aq 10% | A: 9/568; B: 22/549; p<0.05 | A: 3/568; B: 3/549; NS | Conference abstract; colonisation significant | Correct |
| Mimoz et al. 1996 [32] (C) | RCT; CVCs, ACs; insertion and maintenance | A: CHG 0.25% + BAK 0.025% + BALC 4%; B: PVI aq 10% | A: 12/170; B: 24/145; p<0.05 | A: 3/170; B: 3/145; NS | Synergistic combination of three antiseptics in arm A | Correct |
| Legras et al. 1997 [33] (C) | RCT; CVCs, ACs; insertion and maintenance | A: CHG 0.5% + ALC (?%); B: PVI aq 10% | A: 19/179; B: 31/224; NS | A: 0/208; B: 4/249; NS | Differences non-significant | Intermediate |
| Cobbett and LeBlanc 2000 [34] (C) | RCT; PVCs; insertion yes, maintenance not specified | A: CHG 0.5% + IPA 70%; B: ALC (?%) seq PVI aq 10%; C: PVI aq 10% seq ALC (?%) | A: 6/83; B: 12/80; C: 11/81; All NS | ND | Differences non-significant, also when B and C pooled vs A | Correct |
| Humar et al. 2000 [35] (C) | RCT; CVCs; insertion and maintenance | A: CHG 0.5% + ALC (?%); B: PVI aq 10% | A: 36/116; B: 27/116; NS | A: 4/193; B: 5/181; NS | Differences non-significant; sole study with slight disadvantage of CHG + ALC vs PVI aq | Intermediate |
| Maki et al. 2001 [36] (C) | RCT; CVCs, PICCs, ACs; insertion and maintenance | A: CHG 1% + ALC 75%; B: PVI aq 10% | A: 43/422; B: 192/617; p<0.05 | A: 4/422; B: 23/617; p<0.05 | Largest study; biggest difference between study arms | Intermediate |
| Langgartner et al. 2004 [37] (R) | RCT; CVCs; insertion was studied; maintenance all with CHG + ALC | A: CHG 0.5% + IPA 70%; B: PVI aq 10%; C: CHG 0.5% + IPA 70% seq PVI aq 10% | A: 11/45; B: 16/52; C: 2/43; A:C, B:C p<0.05 | ND | Arm C (sequential protocol) significantly better than A or B | Correct |
| Astle and Jensen 2005 [38] (R) | RCT; CVCs (hemodialysis); insertion and maintenance | A: CHG 0.5% + IPA 70%; B: ExSept | ND | A: 1/64; B: 1/57; NS | Study did not report catheter colonisation | Incorrect |
| Kelly et al. 2005 [39] | RCT; CVCs, ACs; insertion and maintenance | A: CHG 2% + IPA 70%; B: PVI aq 10% | A: 4/82; B: 15/82; p<0.05 | A: 1/82; B: 8/82; p<0.05 | Conference abstract; alcohol in arm A only revealed by correspondence | Incorrect |
| Balamongkhon et al. 2007 [40] | Non-RCT; insertion and maintenancef | A: CHG 2% + ETH 70%; B: PVI aq 10% | ND | A: 3/120; B: 7/192; NS | Weak study design, difference non-significant | Intermediate |
| Mimoz et al. 2007 [41] (R) | RCT; CVCs; insertion and maintenance | A: CHG 0.25% + BAK 0.025% + BALC 4%; B: PVI 5% + ETH 70% | A: 28/242; B: 53/239; p<0.05 | A: 4/242; B: 10/239; NS | Rare study with PVI-alcohol; difference for colonisation significant | Intermediate |
| Small et al. 2008 [42] (R) | RCT; PVCs; only insertion, not maintenance | A: CHG 2% + IPA 70%; B: IPA 70% | A: 18/91; B: 39/79; p<0.05 | ND | Significant difference; but mean colony counts lower in IPA alone group | Correct |
| Vallés et al. 2008 [43] (R) | RCT; CVCs, ACs; insertion and maintenance | A: CHG 2% + ALC (?%); B: CHG 2% aq; C: PVI aq 10% | A: 34/226; B: 38/211; C: 48/194; only A:C p<0.05 | A: 9/226; B: 9/211; C: 9/194; all NS | Only difference in arms A vs C in colonisation significant | Correct |
| Garland et al. 2009 [44] | RCT; PICCs; insertion and maintenance | A: CHG 0.5% + ALC (?%); B: PVI aq 10% | A: 3/24; B: 1/24; NS | A: 0/24; B: 0/24; NS | Small study; focus on skin tolerability in neonates | Incorrect |
| Ishizuka et al. 2009 [45] | Non-RCT; CVCs; insertion studied; maintenance all PVI aqf | A: CHG aq 0.05%; B: PVI aq 10% | ND | A: 14/286; B: 6/298; NS | CHG concentration very unusually low | Not applicable |
| Chaiyakunapruk et al. 2002 [46] | Systematic review | 8 eligible trials, 2 with CHG aq, 1 with CHG plus other compounds, 5 with CHG + ALC; comparator for all PVI aq 10% | Relative risk for CHG-containing vs PVI aq was about 0.5 (50%) for colonisation and CR-BSI | See comments under colonisation | Seminal review; basis for multiple recommendations; only CHG + ALC but not CHG aq significant in CR-BSI | Incorrect |
| Rickard and Ray-Barruel 2010 [47] | Systematic review | 7 eligible trials, 5 examined any CHG-containing antiseptic prior to catheter insertion | Any CHG vs any others performed significantly better in colonisation but not in CR-BSI; same for any CHG vs any PVI | See comments under colonisation | Article available on internet; part of Australian national infection control guidelines | Intermediate |
ACs, arterial catheters; ALC, alcohol (when alcohol type not known); aq, aqueous; BAK, benzalkonium chloride; BALC, benzyl alcohol; CHG, chlorhexidine gluconate; CR-BSI, catheter-related bloodstream infection; CVCs, central venous catheters; ETH, ethanol; IPA, isopropanol; ND, not determined; PICCs, peripherally inserted central venous catheters; PVCs, peripheral venous catheters; PVI, povidone iodine; RCT, randomised clinical trial; seq, sequential application; vs, versus; ?%, percentage not specified.
Annotation with (C) or (R) denotes whether original studies were included in the systematic reviews of Chaiyakunapruk et al [46] (C) or Rickard and Ray-Barruel [47] (R).
Mention of insertion and maintenance refers to whether the assigned study antiseptic was used prior to catheter insertion only, or both, for insertion and maintenance.
A, B, and C denote different study arms.
Outcome: number of catheters colonised or CR-BSIs per catheters inserted in each study arm. Significance is indicated either by NS (not significant) or p<0.05 (when significant).
Attribution: assesses whether study outcomes derived from alcohol plus CHG were attributed to CHG alone by authors.
These studies were classified as non-randomised cluster cross-over trials. They had been conducted by prospective sequential implementation of different antiseptic regimens in clinical units.