Otero 2017.

Methods	Trial design: RCT Trial grouping: parallel groups Ethics and informed consent: yes Follow‐up period: followed participants for 5‐10 h following treatment (average treatment 14.5 h) Sample size estimate:a total of 152 participants needed to be recruited. ITT analysis: no; number randomised: 171; number analysed: 152 Funding: not stated
Participants	Adults with acute respiratory failure, requiring non invasive ventilation Inclusion criteria: adults (≥ 18 years) absence of facial soft tissue injury absence of facial anatomy structural deformity Exclusion criteria: people not agreeing to participate and not signing the informed consent form people with facial soft tissue lesions people with any deformity of the facial anatomy Pretreatment 56.6% men; 43.4% women The average Norton score of the total population was 10.69 (SD = 2.85)
Interventions	Intervention groups: adhesive thin dressing (ATD): the oro‐nasal mask was applied over skin protected with adhesive thin polyurethane foam dressings adhesive foam dressing: the oro‐nasal mask was applied over skin protected with adhesive foam dressings HOFA: the oro‐nasal mask was applied over skin protected with a solution of HOFA, gently applied without rubbing on the chin, cheekbones, nasal bridge and forehead Control: The oro‐nasal mask was applied directly over the participant’s skin
Outcomes	PU incidence Outcome type: dichotomous outcome Reporting: fully reported for those analysed Unit of measure: numbers Direction: lower is better Data value: endpoint Adverse events Outcome type: dichotomous outcome Reporting: fully reported for those analysed Unit of measure: numbers Direction: lower is better Data value: endpoint
Identification	Sponsorship source: Istituto Ortopedico Rizzoli Country: Spain Setting: HDU section of an emergency and critical care department in the University General Hospital in Madrid, Spain Comments: no comments Author's name: DP Otero Institution: University General Hospital Gregorio Marañón; Gregorio Marañón Healthcare Research Institute‐Nursing Department (IiSGM); Centre for Health Sciences San Rafael‐Antonio Nebrija University, Email: david.penha.otero@hotmail.com Address: Madrid, Spain
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "we randomised subjects into four different groups, using specifically designed tables of random numbers"
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "As the researchers were also part of the care team at the HDU, it was impossible to implement a blinded study"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "We employed independent double evaluations"
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "A total of 19 patients were lost to follow‐up; 4 died before the end of the trial, and data recording was incomplete for 4 patients"
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	None noted