Measuring skin necrosis in a randomised controlled feasibility trial of heat preconditioning on wound healing after reconstructive breast surgery: study protocol and statistical analysis plan for the PREHEAT trial

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

ISSN: 2055-5784