Yucel 2004.
Methods | Multicentre RCT (Germany) | |
Participants | Hospitalized adult (18‐80 years) surgical patients requiring CVC for at least 3 days and undergoing their first central venous catheterization. Exclusion criteria were pregnancy, known allergy to miconazole and/or rifampicin, anatomic defect or skin lesion at the potential site of insertion, and previous inclusion in the trial | |
Interventions | MR‐impregnated CVCs versus non‐impregnated CVCs | |
Outcomes | Clinically diagnosed sepsis, CRBSI, catheter colonization, catheter‐related local infection and 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) | Low risk | Quote: "A computer‐generated random list with varying block size was generated separately for each of the two participating study centres." |
Allocation concealment (selection bias) | Low risk | Quote: "The information whether to use a modified or non‐modified catheter was put in opaque envelopes with a serial number. After insertion of the catheter the individual identification number was recorded in the patient’s medical chart and on a separate documentation sheet (case report form)." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The authors stated that the trial was 'non‐blinded' |
Blinding of outcome assessment (detection bias) Microbiological outcomes like catheter colonization | Unclear risk | It was unclear whether the assessors of the microbiological outcomes were blinded to the status of the samples |
Blinding of outcome assessment (detection bias) Clinical outcomes like CRBSI | High risk | The authors stated that the trial was 'non‐blinded' |
Incomplete outcome data (attrition bias) All outcomes | High risk | Excluding primary drop‐outs (56 that did not receive CVCs post‐randomization), 37/260 of the participants who received CVCs were excluded (14.2%: 29 in the control group and 8 in the study group). The reasons for exclusion included accidental removal of the catheter by the medical staff (22 in the control group and 1 in the study group) or by the participants (4 in the control group and 1 in the study group), death (2 in the control group and 1 in the study group), or missing microbiological analysis (5 in the control group and 1 in the study group). There were many more drop‐outs from the control group than the study group. The event rates were low, especially for the outcomes of clinically diagnosed sepsis and CRBSI. Overall we felt that this study had a high risk of attrition bias |
Selective reporting (reporting bias) | Unclear risk | All the outcomes specified in the Methods were reported in sufficient detail in the Results |
Other bias | Low risk | None identified |
Abbreviations
CFU = colony‐forming unit
CRBSI = catheter‐related bloodstream infection
C‐SS = chlorhexidine‐silver sulphadiazine
CVC= central venous catheter
ICU = intensive care unit
MR = minocycline‐rifampicin
RCT = randomized controlled trial
SIRS = Systemic Inflammatory Response Syndrome
SPC = silver‐platinum‐carbon
TPN = total parenteral nutrition