Table 6.
Safety events’ data
| Event | Control | Heated | Total |
|---|---|---|---|
| AR | 0 | 1 (1) | 1 (1) |
| SAE | 10 (7) | 20 (15) | 30 (22) |
| SAR | 0 | 0 | 0 |
| Complication | |||
| Mastectomy skin-flap necrosis | 5 | 2 | 7 |
| Infection | 2 | 4 | 6 |
| Haematoma | 2 | 6 | 8 |
| Re-do anastamosis | – | 4 | 4 |
| Flap failure | 1 | 3 | 4 |
| Burn | – | 1 | 1 |
Number of patients shown in brackets as some patients had more than one safety event. AR adverse reaction related to heating protocol, SAE serious adverse event not related to heating protocol, SAR serious adverse reaction related to heating protocol. Note: AE adverse events (not serious and not related to heating protocol) were not recorded in the PREHEAT database