Table 5.

Checklist of criteria to be defined and completed for an optimum design in wound care clinical trials [144].

Criteria	Descriptions
Setting	The trial setting (e.g., home care, general hospital, nursing home, or specialized (university) clinic) is defined
Patients	Eligibility criteria for patients are described (inclusion and exclusion criteria) Written informed consent will be obtained from every patient included
Interventions	The treatment to be used in each trial arm is standardized Cointerventions are allowed but prespecified (the same in both trial groups)
Outcomes	Primary and secondary outcomes are predetermined It is described when and how outcomes are evaluated
Sample size	Sample size is calculated (calculation based on the expected clinically relevant difference in primary endpoint)
Randomization	The unit of randomization is defined (e.g., the wound or the patient) The allocation sequence is randomly generated The treatment allocation is adequately concealed
Blinding	It is defined who is blinded after assignment to the intervention and how, including: - Patients (recommended) - Caregivers (recommended) - Outcome assessors (strongly recommended)
Intention-to-treat	All randomized patients are to be analyzed in the group to which they were allocated
Funding	Funding through unrestricted grants only
Follow-up	Duration of follow-up is defined
Ethics	Ethics review board approval Trial registration