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 |
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Participants |
Inclusion criteria:
Exclusion criteria:
Pretreatment:
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Interventions |
Intervention group: Kang’ huier transparent strip and foam dressing Control group: routine operating room protective measures |
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Outcomes |
PU incidence
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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 |
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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. |