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An overview of the study design is given in figure 4. A computerised randomisation schedule will be prepared by an independent researcher, and using concealed allocation each patient will be assigned to one of three treatments using numeric block randomisation.
Before the randomization allocation, participants will be informed that they will be assigned to one of the two groups.
Participants will be assigned to their treatment allocation prior to the time of surgery by accessing the online randomisation programme.
Participants will be assigned to their treatment allocation at the time of surgery by accessing the online randomisation programme.
Therefore, participants will be assigned to their treatment allocation at the end of the initial surgery, but before the wound dressing is applied.
Following random allocation via a computer generated block randomization schedule, participants will be assigned to one of three intervention arms.
The study subjects will be assigned to one of two groups with a 1 1 allocation ratio by investigator in each study site.
Participants will be assigned to the novel rehabilitation strategy or usual care by random, concealed allocation with an audit trail.
During phase one (the first 16 patients randomised) the remainder of patients will be assigned to one of the six active dexamethasone daily doses with equal allocation probability.
Eligible participants will be assigned to each group using blocked randomization, stratified by the participating centers, with a 1 1 allocation ratio using a confidential block size.
Participants will be assigned to a unique digital trial code to ensure that treatment outcome measurement and statistical analysis will be performed blind to treatment allocation.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com