| Methods |
Trial with follow‐up of 10 days. |
| Participants |
Patients admitted to a District General Hospital for bed‐rest or surgery, with intact skin, no other skin abnormalities, no terminal illness, weight <160 kg.
Mean Waterlow score on admission: Group 1: 14 (3.6); Group 2: 13 (2.5). |
| Interventions |
1. Transfoam mattress (n = 50).
2. Transfoamwave (n = 50) (both foam). |
| Outcomes |
1. 1x grade 4 ulcer.
2. 1x grade 2 ulcer. |
| Notes |
95% follow‐up; ITT analysis. Length of stay, pressure ulcer incidence. Comfort not specified (and only in treatment arm). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Subjects were selected from the admissions using serially numbered, sealed opaque envelopes and allocated to either a study mattress... or a non ‐study mattress.......This form of randomisation ensured that staff were not able to choose which patients be allocated to the study mattress". |
| Allocation concealment (selection bias) |
Low risk |
"Subjects were selected from the admissions using serially numbered, sealed opaque envelopes and allocated to either a study mattress... or a non ‐study mattress.......This form of randomisation ensured that staff were not able to choose which patients be allocated to the study mattress". |
| Blinding (performance bias and detection bias)
Pressure ulcer incidence |
Low risk |
"Subjects were reviewed at 5 and 10 days post admission. Observations of the skin were made and any pressure sores documented; these observations were confirmed blindly by the ward link nurse". |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Numbers not reported post‐baseline. |
| Selective reporting (reporting bias) |
Low risk |
All pre‐specified outcomes reported. |
| Free of other bias ‐ were groups similar at baseline regarding the most important prognostic indicators? |
Unclear risk |
Only data for the treatment arm were provided. People were randomised to a non‐study treatment, but were not followed‐up. |
| Free of other bias ‐ was the timing of the outcome assessment similar in all groups? |
Low risk |
Subjects were reviewed at 5 and 10 days post admission. |
