Forni 2018.

Methods	Trial design: RCT Trial grouping: parallel Ethics and informed consent: unclear Follow‐up period: 8 days Sample size estimate: yes (359 people required) ITT analysis: yes; number randomised: 359; number analysed: 359 Funding: sponsored by the Istituto Ortopedico Rizzoli; ClinicalTrials.gov identifier: NCT02692482
Participants	Inclusion criteria: people aged ≥ 65 years with hip fragility fracture without NPUAP scale stage ≥ 2 PU people or legal guardians who gave their consent to take part in the study Exclusion criteria: people with known allergy to the product being tested or dermatological diseases that prevent the use of topical products people with peri‐prosthetic or pathological fractures people with diaphyseal or distal femoral fractures Pretreatment: age: mean (SD): 84.3 (7.7) multi‐layered dressing incorporating hydrocellular foam, hyper‐absorber, lock‐away core with a silicone wound contact layer; 83.2 (7.7) standard care female: n (%): 144 (81,4%) multi‐layered dressing incorporating hydrocellular foam, hyper‐absorber, lock‐away core with a silicone wound contact layer; 145 (79.7%) standard care
Interventions	Intervention group: application of a multi‐layered dressing incorporating hydrocellular foam, hyper‐absorber lock‐away core with a silicone wound contact layer over the sacral region within 24 h of admission and replaced when detached, wet or dirty in addition to standard care (PU risk assessment using the Braden scale within 24 h of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score < 18, daily inspection of the skin in the various pressure points and moving the patient every 4 h after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure) Control group: standard care: PU risk assessment using the Braden scale within 24 h of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score < 18, daily inspection of the skin in the various pressure points and moving the patient every 4 h after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure
Outcomes	Primary outcome: PU incidence in the sacral anatomical location Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint Secondary outcomes: PU incidence in other anatomical location Outcome type: dichotomous outcome Reporting: not reported Unit of measure: numbers Direction: lower is better Data value: endpoint PU severity Outcome type: dichotomous outcome Reporting: fully reported Unit of measure: numbers Direction: lower is better Data value: endpoint Adverse events: skin irritation/damage Outcome type: dichotomous outcome Reporting: not reported Unit of measure: numbers Direction: lower is better Data value: endpoint
Identification	Sponsorship source: Istituto Ortopedico Rizzoli Country: Italy Setting: elderly population admitted for fragility hip fractures Comments: no comments Author's name: Cristiana Forni Institution: Istituto Ortopedico Rizzoli Email: cristiana.forni@ior.it Address: Bologna, Italy, 40136
Notes	Sponsor: Insituto Ortopedico Rizzoli
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization list in blocks of ten was generated by computer"
Allocation concealment (selection bias)	Low risk	Quote: "Opaque envelopes were used to contain the type of treatment (new polyurethane foam multilayer dressing or standard care) according to the sequence indicated by the list; the envelopes were numbered and tied in blocks of ten".
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label
Incomplete outcome data (attrition bias) All outcomes	Low risk	All those randomised included in the final analysis
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Unclear risk	Baseline comparability not reported