Table 1.
Schedule of enrolment, interventions and assessments for PREHEAT
Study period | |||||
---|---|---|---|---|---|
First clinic appointment with reconstructive surgical team | Pre-assessment for surgery | Day before surgery—treatment period | Day of surgery | Follow-up | |
Action | Day 14 | Day 7 | Day 1 | Day 0 | Days 0–30 |
Eligibility screen | X | ||||
Patient information | X | ||||
Informed consent | X | ||||
Randomisation | X | ||||
Equipment given to patient | X* | ||||
Baseline and pre-operative assessment/variables collected (see Table 2) | X | ||||
Heat preconditioning procedure | X* | ||||
Surgery | X | ||||
Operative assessment/variables collected (see Table 2) | X | ||||
Monitoring for skin necrosis and other post-operative outcomes (see Table 2) | X† | ||||
AE monitoring | X* | X | X |
*For patients randomised to intervention only
†Skin necrosis measurements are taken at the first outpatient appointment (usually 7 days after discharge so approximately day 12–16) then at every outpatient visit following this until day 30–40