| Methods |
Single‐centre RCT (USA) |
| Participants |
Adults 18 years or over who needed a triple‐lumen CVC for TPN. Exclusion criteria: < 18 years of age; unable to give consent; pregnant women; people for whom cultures were not obtained for whatever reason; allergy to sulfa for the Arrowgard group. It appeared that the last 2 criteria referred to postrandomization exclusions |
| Interventions |
C‐SS‐impregnated CVCs versus uncoated CVCs |
| Outcomes |
Catheter colonization, CRBSI, catheter‐related local infection, premature catheter removal and length of hospital stay |
| Notes |
Sources of funding: not stated |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "Patients meeting the enrolment criteria were randomized on the basis of the last digit of the patient’s record number to receive either the antiseptic‐coated Arrowgard or standard triple lumen catheter." The author did not elaborate on how the last digit of the record number was used in randomization, i.e. whether some form of alternate allocation was used or whether a truly randomized sequence was deployed |
| Allocation concealment (selection bias) |
Unclear risk |
See the comments above for Random sequence generation (selection bias). Furthermore, the authors did not provide the source of sequence generation and whether this was independent of allocation |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
There was no description of blinding in the paper, and it was highly unlikely that any blinding occurred as the experimental catheter and control catheter differed in appearance, and there was no description of any measures taken to blind those involved in the study |
| Blinding of outcome assessment (detection bias)
Microbiological outcomes like catheter colonization |
Unclear risk |
There was no description of blinding in the paper, and it was highly unlikely that any blinding occurred as the experimental catheter and control catheter differed in appearance, and there was no description of any measures taken to blind those involved in the study. It was unclear whether the assessors of microbiological outcomes were blinded |
| Blinding of outcome assessment (detection bias)
Clinical outcomes like CRBSI |
High risk |
There was description of blinding in the paper, and it was highly unlikely that any blinding occurred as the experimental catheter and control catheter differed in appearance, and there was no description of any measures taken to blind those involved in the study |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
11/202 (5.5%) participants were excluded postrandomization (7 in the experimental group and 4 in the control group). The reason for exclusion was failure to obtain a culture. The number excluded was small and unlikely to change the results of this study significantly. |
| Selective reporting (reporting bias) |
Unclear risk |
The major outcomes specified and defined in the Methods, including catheter colonization (referred to as 'catheter related infection') and CRBSI (referred to as 'catheter related sepsis') and premature catheter removal were reported in the Results |
| Other bias |
Low risk |
None identified |
