| Methods |
Single‐centre RCT (Australia) |
| Participants |
Quote: "ICU patients who required a CVC for drug administration, parenteral nutrition or monitoring purposes or who were expected to have the device in‐situ for at least five days were eligible for the study." |
| Interventions |
C‐SS‐impregnated CVCs versus non‐impregnated CVCs |
| Outcomes |
Catheter colonization |
| Notes |
The study consisted of 2 parts: first was a comparison between C‐SS‐impregnated CVCs and non‐impregnated CVCs for reducing catheter colonization and second was an evaluation of the Fibrin Analysing System (FAS) brush in detecting early catheter colonization. The first part of the study was included in this review. Sources of funding: industry (catheter manufacturer or distributor) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The word 'randomized' was used in the abstract, but there was no mention of randomization in the full text |
| Allocation concealment (selection bias) |
Unclear risk |
There was no mention of randomization or the methods of allocation |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
There was no mention of blinding in the paper, but blinding appeared unlikely as the 2 types of catheter used differed in appearance, and it was mentioned in the Methods that “Once inserted, the CVC insertion site was covered with a transparent dressing." |
| Blinding of outcome assessment (detection bias)
Microbiological outcomes like catheter colonization |
Unclear risk |
It was not stated whether the assessors of the microbiological outcomes were blinded |
| Blinding of outcome assessment (detection bias)
Clinical outcomes like CRBSI |
High risk |
There was no mention of blinding in the paper, but blinding appeared unlikely as the 2 types of catheter used differed in appearance, and it was mentioned in the Methods that “Once inserted, the CVC insertion site was covered with a transparent dressing." |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
7/61 catheters were excluded from the analysis because the participants "did not complete the five‐day study period." It was unclear how many of the 7 excluded catheters were in each assigned group, and the authors did not provide a description of the participants characteristics of the 2 groups without the 7 excluded participants. The event rates of the outcomes of catheter colonization were comparable to the number of catheters excluded (4 in the study group and 10 in the control group), it was unclear whether the results would have been altered substantially if the data of these excluded catheters had been available |
| Selective reporting (reporting bias) |
High risk |
Catheter colonization was the only outcome reported in this part of the study. Other clinically relevant outcomes like CRBSI and death were not reported |
| Other bias |
Low risk |
None identified |
