Walker 2015.

Methods	Trial design: RCT Trial grouping: parallel groups Ethics and informed consent: yes Follow‐up period: 5 days Sample size estimate: yes: a sample size of 1500 (750 in each group) would be required to test the effectiveness of this intervention ITT analysis: yes; number randomised: 77; number Aanalysed: 77 Funding: this study was funded by the National Health and Medical Research Council’s Centre of Research Excellence in Nursing, and an Early Career Researcher Mentored Grant from the Centre from Health Practice Innovation, Griffith University
Participants	Inclusion criteria: ≥ 18 years of age able to provide written informed consent either in person or via their family member or legal guardian assessed as being at high risk or greater of PI (as per a risk assessment score of 15+ using the Waterlow Scale) on hospital admission to the medical or surgical study wards expected hospital length of stay ≥ 72 h following recruitment Exclusion criteria: suspected or actual spinal injury that prevented the patient being repositioned lower back surgery (lumbar spine) that prevented the application of a sacral dressing existing sacral PI, injury, or allergy in the sacral area at the time of hospital admission faecal incontinence at the time of hospital admission unable to speak or understand English with no interpreter present Pretreatment: age, median: intervention: 77 years; control: 72 years women: intervention: 59%; control: 82% Waterlow median: intervention 17; control 17
Interventions	Intervention group: silicone foam border dressing. Dressing changed every 3 days, skin assessed daily, in addition to usual care Control group: no dressing; usual care only
Outcomes	PU incidence Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint
Identification	Sponsorship source: this study was funded by the National Health and Medical Research Council’s Centre of Research Excellence in Nursing, and an Early Career Researcher Mentored Grant from the Centre from Health Practice Innovation, Griffith University Country: Australia Setting: Surgical Care Unit; the ED; or participating medical and orthopaedic surgical wards Comments: no comment Author's name: Rachel Walker Institution: Princess Alexandra Hospital Email: r.walker@griffith.edu.au Address: Nursing Practice Development Unit, Princess Alexandra Hospital, Building 15, Level 2, Ipswich Road, Woolloongabba QLD 4102
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random allocation of participants to either the routine‐care group or the dressing group was achieved using an online clinical trial co‐ordinating website
Allocation concealment (selection bias)	Low risk	Using an online clinical trial co‐ordinating website accessed by the research nurse using a smart phone or tablet
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unable to blind as one group had a dressing and the other didn't
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Sacral assessment was undertaken by a suitably qualified blind‐to‐intervention (“blinded”) nurse assessor
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants were accounted for
Selective reporting (reporting bias)	Low risk	The published protocol was sighted and outcomes in the study were consistent with those named in the protocol.
Other bias	Low risk	This was a small feasibility study so was not powered to find differences between groups.

ED: emergency department; h: hour(s); HD: hydrocolloid dressing; HDU: high‐dependency unit; HOFA: hyperoxygenated fatty acids; ICU: Intensive Care Unit, Coronary Care Unit (CCU); ITT: intention‐to‐treat analysis; NPUAP: National Pressure Ulcer Advisory Panel; PF: polyurethane film; PI: pressure injury; PPD: pressure ulcer preventative dressing; PU: pressure ulcer; RCT: randomised controlled trial