Smith 1985.
Methods |
Trial design: RCT Trial grouping: parallel groups Ethics and informed consent: yes Follow‐up period: 24 weeks Sample size estimate: not stated ITT analysis: yes; number randomised: 258; number analysed: 258 Funding: grant from WB Pharmaceuticas |
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Participants |
Inclusion criteria:
Exclusion criteria:
Pretreatment
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Interventions |
Intervention group: Conotrane (silicone cream; 20% dimethicone 350; and a broad spectrum antiseptic (0.05% hydrargaphen)), skin washed, dried and ointment applied Control group: Unguentum cream, skin washed, dried and ointment applied |
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Outcomes |
PU incidence
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Identification |
Sponsorship source: WB Pharmaceuticals Country: UK Setting: long stay Comments: no comment Author's name: RG Smith Institution: Department of Geriatric Medicine Email: not stated Address: City Hospital, Greenbank Drive, Edingburgh, UK |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The placebo ointment had been suitably scented so that it was indistinguishable from the active preparation" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No mention within the article; quote: "The placebo ointment had been suitably scented so that it was indistinguishable from the active preparation" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Results table 1: of 258 participants Data presented related to those who entered the study |
Selective reporting (reporting bias) | Low risk | All outcomes reported in the paper were those outlined by the trial authors |
Other bias | Unclear risk | One third more participants in the placebo group were incontinent of urine and one quarter more were incontinent of faeces when compared with the treatment group. |