PubMed · 10539086
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1999. Top 50 nursing facility chains.. https://pubmed.ncbi.nlm.nih.gov/10539086/
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A sequential double blind (assessor and patient) triangular design was used to compare the incidence of pressure sores following elective major surgery among patients lying on a standard foam mattress with those on a dry visco-elastic polymer pad during their operation. A total of 446 patients were recruited into the trial between 1994 and 1996. Interim analyses were carried out after 181 patients were entered into the trial and then subsequently after approximately every 100 patients recruited. The trial unexpectedly reached a stopping boundary at the first interim analysis, however the Independent Data Monitoring Committee recommended continuation of the trial. They were concerned that there was a need for a larger definitive trial and about an apparent treatment by centre interaction. They required a substudy to be undertaken to further validate the subjective endpoint, and that further sensitivity analyses of the main trail endpoint should be carried out in the second interim analysis. The trial was stopped at the third interim analysis when again a stopping boundary was crossed indicating that the gel pad was associated with significantly fewer pressure sores than the standard mattress (log odds ratio -0.7, (95 per cent confidence interval (CI), -1.28, -0.11), p=0.02) (estimate CI, p-value adjusted for group sequential conduct). The design, monitoring and analysis of this trial will be presented as an example of the practical problems or non-problems encountered for the local hospitals, for the trials unit, for the data monitoring committee and for the funding committee.
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OBJECTIVES: To assess the effectiveness of pressure relieving beds, mattresses and cushions (support surfaces) in the prevention and treatment of pressure sores. SEARCH STRATEGY: Searches of 19 databases, hand searching of journals, conference proceedings, and bibliographies. SELECTION CRITERIA: Randomised controlled trials evaluating support surfaces for the prevention or treatment of pressure sores. There was no restriction on articles based on language or publication status. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality was undertaken by two reviewers independently. Trials with similar patients, comparisons, and outcomes were pooled. Where pooling was inappropriate, trials are discussed in a narrative review. MAIN RESULTS PREVENTION: 29 RCTs of support surfaces for pressure sore prevention were identified. Some high specification foam mattresses were more effective than 'standard' hospital foam mattresses in moderate-high risk patients. Pressure relieving mattresses in the operating theatre reduced the incidence of pressure sores post-operatively. The relative merits of alternating and constant low pressure, and of the different alternating pressure devices are unclear. Seat cushions and simple, constant low-pressure devices have not been adequately evaluated. Limited evidence suggests that low air loss beds reduce the incidence of pressure sores in intensive care. TREATMENT: 6 RCTs of support surfaces for pressure sore treatment were identified. There is good evidence that air-fluidised and low air loss beds improve healing rates. Seat cushions have not been adequately evaluated. 2 RCTs evaluated surfaces for both prevention and treatment in the same trial. REVIEWER'S CONCLUSIONS: PREVENTION - There is good evidence of the effectiveness of high specification foam over standard hospital foam, and pressure relief in the operating theatre. Treatment - There is good evidence of the effectiveness of air-fluidised and low air loss devices as treatments. Overall, however, it is impossible to determine the most effective surface for either prevention or treatment.