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

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
Participants Inclusion criteria:
  • people with intact skin


Exclusion criteria:
  • not stated


Pretreatment
  • age, mean: intervention: 82 years; control: 83 years

  • gender, F/M: intervention: 104/25; control: 106/23

  • incontinent urine: intervention: 19%; control: 29%

  • incontinent faeces: intervention: 29%; control: 42%

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
Outcomes PU incidence
  • Outcome type: dichotomous outcome

  • Reporting: fully reported

  • Unit of measure: numbers

  • Direction: lower is better

  • Data value: endpoint

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
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.