EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial

Table 1 Participant timeline based on the SPIRIT statement [19]

	Study period
	Enrolment and allocation	Baseline data collection	Daily data collection (post-allocation)		Study exit	Evaluation	Trial close-out
Time point			*Up to 14 days* Prevention	*Up to 28 days^e Treatment*
Enrolment (within 36 h of hospital admission)
Eligibility screen	X
Informed consent	X
Allocation (randomisation)	X
Baseline data collection
Hospital information		X
Participant demographics		X
Participant health data		X
PI risk assessment		X
Photography of the sacrum		X
Application of dressing (intervention only)		X
Intervention
Routine care only			X
Routine care + prophylactic dressing			X
Outcome variables
Skin assessment^a			X
De-identified photograph of the sacrum and photo editing			X
Dressing change/reason^b			X
HAPI			X
Other complications^c			X
Economic evaluation
Hospital length of stay^d					X
Dressing used for HAPI			X
Staff time to apply, remove, and change dressing for prevention (subsample)			X
Resources used to treat any local adverse effects of dressings for prevention			X
Other resources used to prevent HAPI			X
Resources (including dressings) used to treat HAPI				X
Process evaluation [16]
Context			X	X		X
Fidelity			X	X		X
Dose delivered			X	X		X
Dose received (exposure)			X	X		X
Recruitment	X	X				X
Reach	X	X				X
Discharge, death, or withdrawal					X
*Reports to HREC, funding body, site visits, DSMB meetings*							X^f

HAPI hospital-acquired pressure injury, HREC Human Research Ethics Committee, DSMB Data Safety Monitoring Board
^aParticipants’ demographic and clinical data, e.g. gender, diagnosis, reason/type of admission, mobility status, body mass index (BMI), nutritional deficiencies, the type of and number of comorbidities, smoking status, PI risk, existing PI (other than sacral) and its treatment/management, previous history of PI, number of days enrolled in the trial, and hospital length of stay, will be recorded in a separate electronic case report form
^bDressing change/reason = may include skin itchiness/irritation dressing soiled, rolled-up, saturated, in situ for more than several days or as indicated by clinical practice (as per manufacturer recommendations), or other device deficiency
^cOther complications = allergic reaction, persistent faecal incontinence, unable to be moved
^dHospital length of stay recorded for all trial participants
^eOnly relevant for participants who develop HAPI within the 14-day trial will be followed up until day 28
^fReports to HREC, funding body, site visits, and DSMB meetings are also completed at multiple, specific time points during the trial (e.g. annual HREC reports)

ISSN: 1745-6215