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

Han 2011.

Methods Trial design: RCT
Trial grouping: parallel
Ethics and informed consent: unclear
 Follow‐up period: 3 days
Sample size estimate: no
ITT analysis: yes; number randomised: 100; number analysed: 100
Funding: sponsored by manufacturers of the interventional product
Participants Inclusion criteria:
  • people admitted for posterior spinal surgery


Exclusion criteria:
  • people with previous skin disease,

  • those undergoing emergency surgery

  • those with operation time of < 3 h


Pretreatment:
  • not stated

Interventions Intervention group: Kang’ huier transparent strip and foam dressing
Control group: routine operating room protective measures
Outcomes PU incidence
  • Outcome type: dichotomous outcome

  • Reporting: fully reported

  • Unit of measure: numbers

  • Direction: lower is better

  • Data value: endpoint

Identification Sponsorship source: Shandong Province Higher Education Reform Project
Country: China
Setting: spinal surgery
Comments: no comments
Author's name: MF Green
Institution: a third‐grade class‐A hospital of Qingdao city
Email: none provided
Address: Nursing College of Medical College of Qingdao University, Shandong 266021 China
Notes Authors state that the 2 PUs in the intervention group occurred outside the treated area
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described, states only that participants were randomly grouped. But authors did not explain how the sequence was generated
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding impossible due to the nature of the intervention
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Blinding impossible due to the nature of the intervention
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 100 participants enrolled and all accounted for in the results
Selective reporting (reporting bias) Low risk The only outcome pre‐specified was "pressure sore"
Other bias Unclear risk We had only the most important data interpreted. It is possible that there may have been biases about which we are unaware.