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

Saab 2015.

Methods Trial design: RCT
Trial grouping: parallel groups
Ethics and informed consent: not stated
Follow‐up period: not stated
Sample size estimate: not stated
ITT analysis: yes; number randomised: 80; number analysed: 80
Funding: not stated
Participants Inclusion criteria:
  • people admitted to SICU from July‐November 2014


Exclusion criteria:
  • not reported


Pretreatment:
  • 44% women

  • mean age was 62 (17.2) years

  • mean Braden score was 15.1

Interventions Intervention group:
  • application of a multi‐layered dressing incorporating hydrocellular foam, hyper‐absorber, lock‐away core with a silicone wound contact layer

  • the buttocks and the sacrum were examined daily

  • the dressing was replaced as needed


Control group:
  • no dressing

Outcomes PU incidence
  • Outcome type: dichotomous outcome

  • Unit of measure: numbers

  • Direction: lower is better

  • Data value: endpoint

Identification Sponsorship source: not reported
Country: USA
Setting: surgical ICU
Comments: no comment
Author's name: I Saab
Institution: Henry Ford Hospital
Email: not provided
Address: 2799 West Grand Boulevard, Detroit, MA 48202
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation not stated
Allocation concealment (selection bias) Unclear risk Not stated
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 Outcomes reported for those randomised to each group
Selective reporting (reporting bias) Low risk PU incidence reported
Other bias Unclear risk As this is an abstract, this element is unclear