Aspect of the trial | Amendment made |
---|---|
Wound measurements | Depth measurement will be conducted by swab or probe |
Adverse events | Serious, related, and ongoing events will be followed up for 1 month after trial exit |
Clarification of definitions of unplanned and prolonged hospitalisation | |
Intervention/control | Frequency of surgical wound dressing changes will be recorded |
Addition of further trial device (PICO® – Smith and Nephew) | |
Study processes | Patients who have their reference wound amputated will continue to be followed up for participant-reported measures |
Patient and Public Involvement (PPI) | Patients in the SWHSI trial will be approached at the end of their trial involvement, with regards involvement in a PPI group. |