Torra i Bou 2005.

Methods	Trial design: RCT Trial grouping: parallel groups Ethics and informed consent: yes Follow‐up period: 30 days Sample size estimate: yes, 188 people per group required ITT analysis: no; number randomised: 380; number analysed: 359 Funding: Laboratorios Bama‐Geve SA, Barcelona, Spain
Participants	Inclusion criteria: participants had to be at medium, high or very high risk of developing PUs participants had to be able to participate for an evaluation period of 30 days participants or their carers needed to provide written consent to take part Exclusion criteria: were terminally ill or receiving chemotherapy had > 3 PUs were allergic to HOFA or topical fatty products had peripheral vascular disease Pretreatment age, mean (SD): intervention: 84.8 (6.7); control: 84.8 (5.9) gender: F/M: intervention: 48/17; control: 46/19
Interventions	Intervention group: Mepentol, a HOFA compound (consisting of: oleic acid, palmitic acid, stearic acid, palmitoleic acid, linoleic acid, gamma‐linoleic acid, arachidonic acid, and eicosenoic acid), applied twice daily to ≥ 3 areas of the body, sacrum, trochanter, heels Control group: a compound consisting of trisostearin (99.4%) and perfume (0.6%) applied twice daily to ≥ 3 areas of the body, sacrum, trochanter, heels
Outcomes	PU incidence Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint Cost benefit Outcome type: continuous outcome Reporting: partially reported Unit of measure: Euro Direction: lower is better Data value: endpoint
Identification	Sponsorship source: Laboratorios Bama‐Geve SA, Barcelona, Spain. Country: Spain Setting: internal medicine or surgical patients at high risk of pressure injury Comments: no comment Author's name: J E Torra i Bou Institution: Clinical and Education Manager, Advanced Wound Care Division, Smith & Nephew, Spain; Email: jetorrabou@hotmail.com Address: not stated
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Did not state how the randomisation sequence was generated
Allocation concealment (selection bias)	Unclear risk	Coded randomisation in closed envelope, did not state that the envelopes were opaque
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinded, quote: "only the coordinator had access to the packaging codes so neither the investigator nor patient knew which group a patient had been allocated to"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded, "only the coordinator had access to the packaging codes so neither the investigator nor patient knew which group a patient had been allocated to"
Incomplete outcome data (attrition bias) All outcomes	High risk	ITT not conducted, results presented for 167 and 164 participants and not for the original 380 enrolled
Selective reporting (reporting bias)	Low risk	All outcomes reported in the paper were those outlined by the trial authors
Other bias	Low risk	None detected