Sherertz 1996.
| Methods | Multicentre RCT (USA) | |
| Participants | Quote: "Patients in intensive care unit". Exclusion criteria: patients < 18 years of age, with dermatitis over the proposed insertion site, neutropenia, pregnant, or allergic to topical disinfectants including chlorhexidine. No patient was enrolled in the study twice | |
| Interventions | Chlorhexidine‐impregnated CVCs versus non‐impregnated CVCs | |
| Outcomes | Catheter colonization, CRBSI, catheter‐related local infection, premature catheter removal | |
| Notes | Sources of funding: industry (catheter manufacturer or distributor) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “This was a two‐armed, randomized, double‐blind, multicenter trial. It was carried out in the intensive care units of four tertiary‐care university hospitals.” There was no statement on how random sequence was generated |
| Allocation concealment (selection bias) | Unclear risk | There was no information about how allocation was performed that would enable an assessment of whether the random sequence was generated independently of allocation |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The authors described this as a 'double‐blind' study and stated that "The catheters coated with chlorhexidine were identical in appearance to uncoated catheters". It was likely that the participants and personnel were blinded to the catheter type |
| Blinding of outcome assessment (detection bias) Microbiological outcomes like catheter colonization | Unclear risk | There were no specific statements on whether the assessors of the microbiological outcomes were blinded |
| Blinding of outcome assessment (detection bias) Clinical outcomes like CRBSI | Low risk | The authors described this as a 'double‐blind' study and stated that "The catheters coated with chlorhexidine were identical in appearance to uncoated catheters". It was likely that the participants and personnel were blinded to the catheter type |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 9/263 catheters (3.4%) were excluded from the analysis because "the catheters were removed from eight patients without culturing and incomplete data entry occurred for one patient." It was unclear how many of these excluded catheters were assigned to the study group and how many were assigned to the control group. Furthermore, as the event rates were low for the outcomes of CRBSI and catheter‐related local site infection, it was unclear whether the inclusion of these 9 catheters, had their outcome data been available, would have altered the results |
| Selective reporting (reporting bias) | High risk | All the outcomes specified in the Methods were reported in sufficient detail in the Results. However, all the outcomes were presented as percentages, and we could not translate most of these into round figures for meta‐analysis, taking the possible total sample as denominators |
| Other bias | Low risk | None identified |