Type of adverse event | Treatment group | |
---|---|---|
NPWT | SC | |
Serious: | - | - |
Death | 2 | - |
Admission to hospital | 1 | 3 |
Other medically important condition | - | 1 |
Persistent/significant disability/incapacity | - | - |
Life-threatening risk (immediate risk of death) | - | - |
Participants cannot provide on-going consent | - | - |
Systemic infection/sepsis | - | - |
Osteomyelitis | 1 | - |
Non-serious adverse events: | - | - |
Wound infection | 2 | 1 |
Skin damage | - | 1 |
Wound bleeding | - | - |
Breakdown of wound following closure surgery | - | - |
Pain | 1 | - |
Recurrence of pressure ulcer (grade II or above) at site of reference pressure ulcer | - | - |
New pressure ulcer (grade II or above) | - | - |
Other event* | 9 | 6 |
Total | 16 | 12 |