Kalowes 2016.

Methods	Trial design: RCT Trial grouping: parallel Ethics and informed consent: ethics approval obtained, exemption from consent obtained. Follow‐up period: participants were followed by the research team until discharged from the ICU (range 4‐14 days). Information about subsequent PU development was retrieved from the electronic medical record. Sample size estimate: yes, estimated as requiring 185/group ITT analysis: yes; number randomised: 366; number analysed: 366 Funding: not declared in the published paper, but a report of a conference presentation declared support for the study by Molnlycke; manufacturer of the intervention product
Participants	Inclusion criteria: all critically ill people admitted to an ICU in a large Level 2 Magnet hospital ≥ 18 years Braden score ≤ 13 intact skin Exclusion criteria: Braden score ≥ 14 existing PU moisture‐related skin damage receiving end‐of‐life care Pretreatment age, mean (SD): intervention: 64.6 (17.7) years; control: 67.3 (16.2) years women, n (%): intervention: 81 (44.0); control: 82 (45.1) Braden score, mean (SD): intervention: 11.8 (1.3); control: 11.9 (1.4) ≥ 4 comorbid conditions, n (%): intervention: 66 (35.9); control: 67 (36.8) APACHE III score, mean (SD): intervention: 58.6 (29.3); control: 49.5 (23.6) baseline characteristics did not differ significantly between the groups
Interventions	Intervention group: silicone dressing (Meplex border sacrum) was applied within 24 h of admission. Dressing changed every 3 days or when soiled or dislodged. Usual care was also provided. Control group: usual care (no dressing). Usual care consisted of Braden scoring on admission and every shift; full skin assessment every shift; use of a special bed; routine positioning; heel off‐loading; incontinence skin care
Outcomes	Primary outcome: PU incidence Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint Secondary outcomes: Stage of PUs Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint Location of PUs Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: none Data value: endpoint
Identification	Sponsorship source: Molnlycke Country: USA Setting: medical/surgical/trauma ICU and a cardiac ICU Comments: no comments Author's name: Peggy Kalowes Institution: Memorial Care Health System Email: p.kalowes@memorialcare.org Address: Longbeach Memorial, 2801 Atlantic Avenue, Long Beach CA, 90806, USA
Notes	Unclear if the intervention was continued following discharge from the ICU, although PU incidence was collected. Also unclear but unlikely that nurses diagnosing PUs in the post‐ICU wards underwent inter‐rater reliability testing.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation, quote: "using a computerized research randomiser"
Allocation concealment (selection bias)	Unclear risk	Quote: "Randomization of participants was undertaken by the principal investigator or study nurse" Comment: unclear if allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not stated, but difference in the appearance of dressing makes blinding impossible
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Dressing pulled back daily for routine skin assessment"
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for
Selective reporting (reporting bias)	Low risk	All expected outcomes reported
Other bias	Unclear risk	Information about the study only available as conference abstract