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 |
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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 |
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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 |
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Outcomes |
Primary outcome: PU incidence
Secondary outcomes: Stage of PUs
Location of PUs
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Identification |
Author's name: Chiew SF Institution: Department of Orthopaedic Surgery, Singapore General Hospital, Singapore Email: not stated Address: not stated |
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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 |