Cesaro 2009.

Study characteristics
Methods	Study design: prospective parallel RCT, at a single tertiary referral centre, during a 25‐month study period Method of randomisation: computer generated Allocation concealment: sealed envelopes
Participants	Country: Italy Setting: single tertiary referral centre Numbers: 203 paediatric haematology or oncology patients with tunnelled Broviac CVC. 101 participants randomised to intervention arm and 102 participants randomised to control arm Age: 0 to 17 years; age < 5 years = 39, age > 5 years = 62 in intervention arm; age < 5 years = 41, age > 5 years = 61 in control arm Gender: 60 male, 41 female in intervention arm; 60 male, 42 female in control arm Catheter days at risk: total of 75,249 catheter days. Mean of 381 days per person (range 11 to 1072) in the intervention arm; 351 days per person (range 4 to 1073) in the control arm Inclusion criteria: paediatric patient (0 to 17 years of age, with malignant or non‐malignant haematologic or oncologic disease with a Broviac‐Hickman‐type CVC i.e. tunnelled, partially inserted, open‐ended, inserted for the purpose of chemotherapy of haematopoietic stem cell transplantation Exclusion criteria: not stated
Interventions	Intervention arm: flushing with normal saline at least weekly via a positive pressure cap Control arm: flushing with 3 mL of normal saline with 200 units heparin twice weekly via a standard CVC cap
Outcomes	Incidence of CVC complications: occlusion, dislocation of CVC, CVC‐related infection, exit site infection, thrombosis CVC survival (weeks) Organisms isolated from blood cultures
Notes	Potential confounding of results due to outcomes being attributable to positive pressure cap or frequency between flushes rather than the flushing solution used
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Computer generated randomisation lists were drawn up by a statistician not involved in patient management"
Allocation concealment (selection bias)	Low risk	Quote: "Stored by sequentially numbered sealed envelopes. Permuted blocks of four were used for treatment allocation. Information concealed to investigators until completion of recruitment"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: no blinding of participants or personnel. Different caps were used in the different arms of the study
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: due to nature of interventions, not possible to blind assessment of outcomes
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: low attrition rate; follow‐up for median of 360 days; results from all enrolled participants were reported
Selective reporting (reporting bias)	Unclear risk	Comment: all nominated outcome data were reported. No study protocol available
Other bias	High risk	Comment: outcomes could also be attributed to different caps, or frequency of flushing, not only to use of different solutions