Houwing 2008.
Methods |
Trial design: RCT Trial grouping: cluster Ethics and informed consent: yes Follow‐up period: 4 weeks Sample size estimate: no ITT analysis: yes; number randomised: 79; number analysed: 79 Funding: not stated |
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Participants |
Inclusion criteria:
Exclusion criteria:
Pretreatment
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Interventions |
Intervention group: massage using a "DMSO‐cream". This cream consisted of 5% dimethyl sulfoxide in Vaseline‐cetomacrogol cream, combined with a 30° position change. This procedure was repeated every 6 h for 4 weeks Placebo: 3‐min massage of the buttock, heel, and ankle regions with an "indifferent" cream (Vaseline‐cetomacrogol) combined with a 30° position change. This procedure was repeated every 6 h for 4 weeks Control: 30° position change, repeated every 6 h for 4 weeks |
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Outcomes |
PU incidence
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Identification |
Sponsorship source: not stated Country: the Netherlands Setting: 8 nursing homes Comments: no comments Author's name: R Houwing Institution: Department Dermatology, Deventer Ziekenhuis Email: houwingr@dz.nl Address: Department Dermatology, Deventer Ziekenhuis, The Netherlands |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Throw of a dice (additional information from the study author) |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Stated as double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded, quote: "presence of a pressure ulcer confirmed by two external observers" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None excluded |
Selective reporting (reporting bias) | Low risk | Outcome measure was the presence of a PU, this was reported by the study authors |
Other bias | Unclear risk | There is no indication that the cluster design was accounted for in the analysis |