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. 2018 Dec 6;2018(12):CD009362. doi: 10.1002/14651858.CD009362.pub3

Chiew 2010.

Methods Trial design: RCT
Trial grouping: parallel
Ethics and informed consent: not reported
 Follow‐up period: not reported
Sample size estimate: not reported
ITT analysis: yes; number randomised 109: number analysed:109
Funding: not reported
Participants Country: Singapore
 Setting: orthopaedic ward
Number: 109 (intervention group 54 participants); (control group: 55 participants)
 Inclusion criteria: people > 60 (mean age not reported by group), with traumatic hip fractures who had surgical intervention
Exclusion criteria: not stated
Pretreatment: most of the participants were female (71.6%), 76 years old and above (58.7%), and community ambulant (57.8%) prior to the hip fracture
Interventions Intervention group: Sanyrene® solution and 2–3 hourly change of position. The topical agent was applied on the patient's sacrum, buttocks and heels at every change of position from day of admission
Control group: 2–3 hourly change of position only
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: partially reported

  • Unit of measure: numbers

  • Direction: lower stage is better

  • Data value: endpoint


Location of PUs
  • Outcome type: dichotomous outcome

  • Reporting: partially reported

  • Unit of measure: numbers

  • Direction: none

  • Data value: endpoint

Identification Author's name: Chiew SF
Institution: Department of Orthopaedic Surgery, Singapore General Hospital, Singapore
Email: not stated
Address: not stated
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Although block randomisation was mentioned, the method of sequence generation was not (i.e. computer generated; random numbers list; toss of coin etc)
Allocation concealment (selection bias) Unclear risk The method of allocation concealment was not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk The nature of the intervention would make blinding of participants and personnel impossible
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Reported the incidence of PUs for all those enrolled in the study
Selective reporting (reporting bias) Low risk Results were reported for all participants recruited
Other bias Unclear risk As the data have been extracted from an abstract it is unclear if there are any other sources of bias