Design
The study was a double-blinded placebo-controlled randomized clinical
trial.
A total of 68 patients were enrolled in the intervention group and 47
patients in the control group. Randomization was performed one week
before removal of the CVC. The randomization was performed by the
pharmacy at Aarhus University Hospital who also wrapped and labelled the
cream. In the intervention group 34 patients were assigned to fusidic
acid with betamethasone during patch occlusion (active group), and 34
were assigned to fusidic acid during patch occlusion (placebo group). Of
the 68 patients assessed for eligibility and randomization, 24
participants were excluded due to lack of acceptance of the patch by the
child, forgetting to lubricate with the cream or relapse of the
malignancy. The 47 patients in the control group were retrospectively
collected among patients at the division of pediatric oncology,
department of pediatrics, Aarhus University Hospital, who had their CVC
removed in the years immediately before the start of the trial (Fig. 1).