A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial

Table 1 Time schedule of enrolment, interventions and assessments

	STUDY PERIOD
	Enrolment	Allocation	Post-allocation
TIMEPOINT	-t₁	0	*Day 1*	*1 wk.*	*6 wk.*	3 *mos.*	*6 months*
ENROLMENT:
Eligibility screen	X
Informed consent	X
Allocation		X
INTERVENTIONS:
Mastectomy with drainage		X
Mastectomy without drainage		X
ASSESSMENTS:
*Baseline characteristics*	X	X
*Clinical assessment seroma and complications*				X	X	X	X
*Invasive interventions*			X	X	X	X	X
*SSI*				X	X	X	X
*Cosmesis*				X	X	X	X
*Additional OPD visits*				X	X	X	X
*Wound pain*				X

ISSN: 1471-2407