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Table 2 Protocol amendments made following commencement of the trial

From: Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial

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.

  1. SWHSI surgical Wounds Healing by Secondary Intention