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. 2016 Jul 13;2016(7):CD010140. doi: 10.1002/14651858.CD010140.pub2

Levy 1988.

Methods Single‐centre RCT (USA)
Study period: not reported
Setting: no clear description of the study setting except that the study was conducted on "patients undergoing coronary artery surgery".
Participants 'Patients and methods': "60 patients scheduled for coronary artery surgery were studied during right internal jugular vein cannulation for PA catheter insertion."
Number of participants: 60
Number of catheters;60
Age: not reported
Sex: not reported
Interventions Comparison of 2 skin preparation regimes before insertion of CVC.
  1. Intervention A: 1 minute‐cleaning with 70% isopropyl alcohol followed by draping with a sterile non‐absorbent sheet with an iodophor‐impregnated adherent film placed over the aperture.

  2. Intervention B: povidone‐iodine swabs followed by draping with a sterile non‐absorbent sheet.

Outcomes
  • Catheter colonisation

  • Bacterial contamination of surgical gloves


Outcomes assessed at various points during in‐patient stay.
Notes Funding source: not stated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk 'Patients and methods': "Patients were assigned randomly assigned to one of two groups."
There was no further information, including on random sequence generation.
Allocation concealment (selection bias) Unclear risk There was no information in the paper to enable an assessment on whether random sequence generation was independent from allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Although the authors did not explicitly say, blinding of the patient and personnel was highly unlikely because the 2 skin antisepsis regimes differed in the way of administration (1 using a liquid solution and an additional adherent film and the other using a swab without an adherent film).
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding for microbiological outcome assessment not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Authors analysed all 60 participants initially enrolled and seemed to follow the intention‐to‐treat principle.
Selective reporting (reporting bias) High risk Authors reported both major outcomes named in the 'Methods', catheter colonisation and positive glove culture, in sufficient detail in the 'Results'. However, they did not include major patient‐related outcomes such as catheter‐related BSI, sepsis or mortality.
Other bias Low risk None identified