Table 9.
Adverse events according to treatment group
| 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 |
*Details of these are provided in Table 10.