Mistiaen 2009.
Methods | RCT with 30‐day follow‐up. | |
Participants | Patients recruited from aged care facility (predominantly rehabilitation department) and rehabilitation centre. Grade 1 pressure ulcers included in the sample. | |
Interventions | 1. Australian medical sheepskin within 48 h of admission on the patient's bed. Application in wheelchair recommended and under heels permitted. (Hi‐temp, urine resistant, size XXL mattress) (n = 271).
2. Usual care (n = 272). Cointerventions: usual intervention for prevention of pressure ulcers in study settings. |
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Outcomes | Number and grade of pressure ulcers developed. 1. Grade 1 = 18, Grade 2 = 6, Grade 3 = 0, Grade 4 = 0. 2. Grade 1 = 32, Grade 2 = 6, Grade 3 = 2, Grade 4 = 0. | |
Notes | ITT analyses performed. Sample size calculation performed, however, not included in this paper (included in published protocol). 33% of intervention group believed the sheepskin to be too warm, and thus the trial was stopped early in these patients. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Truly random methods of randomisation used. |
Allocation concealment (selection bias) | Low risk | Adequate methods of allocation concealment used. |
Blinding (performance bias and detection bias) Pressure ulcer incidence | High risk | No blinding on patients, clinicians, outcome assessors. Unclear/unstated blinding of data analysts. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported. |
Selective reporting (reporting bias) | Unclear risk | Not reported. |
Free of other bias ‐ were groups similar at baseline regarding the most important prognostic indicators? | Low risk | Groups were well matched. |
Free of other bias ‐ was the timing of the outcome assessment similar in all groups? | Low risk | No other concerns. |