Pressure relieving support surfaces: a randomised evaluation. Preventing pressure ulcers with the Australian Medical Sheepskin: an open-label randomised controlled trial. Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis. Effectiveness of an alternating pressure air mattress for the prevention of pressure ulcers. An economic appraisal of the Australian Medical Sheepskin for the prevention of sacral pressure ulcers from a nursing home perspective. Clinical effectiveness of a low-tech versus high-tech pressure-redistributing mattress. A clinical evaluation of the Nimbus 3 alternating pressure mattress replacement system. Mattress replacement or foam overlay? A prospective study on the incidence of pressure ulcers. A 4-cm thermoactive viscoelastic foam pad on the operating room table to prevent pressure ulcer during cardiac surgery.
To determine differences between alternating pressure overlays and alternating pressure replacement mattresses with respect to the development of new pressure ulcers, healing of existing pressure ulcers, patient acceptability and cost-effectiveness of the different pressure-relieving surfaces. Also to investigate the specific additional impact of pressure ulcers on patients' well-being.
                A multicentre, randomised, controlled, open, fixed sample, parallel-group trial with equal randomisation was undertaken. The trial used remote, concealed allocation and intention-to-treat (ITT) analysis. The main trial design was supplemented with a qualitative study involving a purposive sample of 20-30 patients who developed pressure ulcers, to assess the impact of the pressure ulcers on their well-being. In addition, a focus group interview was carried out with clinical research nurses, who participated in the PRESSURE (Pressure RElieving Support SUrfaces: a Randomised Evaluation) Trial, to explore the experiences of their role and observations of pressure area care.
                The study took place in 11 hospital-based research centres within six NHS trusts in England.
                Acute and elective patients aged 55 years or older and admitted to vascular, orthopaedic, medical or care of the elderly wards in the previous 24 hours were investigated.
                Patients were randomised to either an alternating pressure overlay or an alternating pressure mattress replacement, with mattress specifications clearly defined to enable the inclusion of centres using products from different manufacturers, and to exclude hybrid mattress systems (which either combine foam or constant low pressure with alternating pressure in one mattress, or can be used as either an overlay or a replacement mattress).
                Development of a new pressure ulcer (grade < or =2, i.e. partial-thickness wound involving epidermis/dermis only) on any skin site. Also healing of existing pressures ulcers, patient acceptability and cost-effectiveness.
                In total, 6155 patients were assessed for eligibility to the trial and 1972 were randomised: 990 to the alternating pressure overlay (989 after one postrandomisation exclusion) and 982 to the alternating pressure mattress replacement. ITT analysis found no statistically significant difference in the proportions of patients developing a new pressure ulcer of grade 2 or above [10.7% overlay patients, 10.3% mattress replacement patients, a difference of 0.4%, 95% confidence interval (CI) -2.3 to 3.1%, p = 0.75]. When logistic regression analysis was used to adjust for minimisation factors and prespecified baseline covariates, there was no difference between the mattresses with respect to the odds of ulceration (odds ratio 0.94, 95% CI 0.68 to 1.29). There was no evidence of a difference between the mattress groups with respect to time to healing (p = 0.86). The Kaplan-Meier estimate of the median time to healing was 20 days for each intervention. More patients allocated overlays requested mattress changes due to dissatisfaction (23.3%) than mattress replacement patients (18.9%, p = 0.02) and more than one-third of patients reporting difficulties associated with movement in bed and getting into or out of bed. There is a higher probability (64%) that alternating mattress replacements are cost-saving; they were associated with lower overall costs (74.50 pounds sterling per patient on average, mainly due to reduced length of stay) and greater benefits (a delay in time to ulceration of 10.64 days on average). Patients' accounts highlighted that the development of a pressure ulcer could be pivotal in the trajectory from illness to recovery, by preventing full recovery or causing varied impacts on their quality of life.
                There is no difference between alternating pressure mattress replacements and overlays in terms of the proportion of patients developing new pressure ulcers; however, alternating pressure mattress replacements are more likely to be cost-saving. The results suggest that when renewing alternating pressure surfaces or ordering equipment within a rental contract, mattress replacements should be specified; however, overlays are acceptable if no replacement mattress is available. Similarly, patient preferences can be supported, without any great increase in risk, if individual patients request an overlay rather than a replacement mattress. Further research could include a randomised controlled trial comparing alternating pressure mattress replacements and high-specification foam mattresses in patients at moderate to high risk; an accurate costing study to understand better how much pressure ulcers cost health and social services in the UK; and trials in higher risk groups of patients. Also future trials should measure time to ulceration as the primary end-point, since this is more informative economically and possibly also from a patient and clinical perspective. To estimate the effectiveness of a new high-performance Australian medical sheepskin (meeting Australian Standard 4480.1-1998) in preventing pressure ulcers in a general hospital population at low to moderate risk of these ulcers.
                Open-label randomised controlled clinical trial.
                A large metropolitan teaching hospital in Melbourne, Victoria, in 2000.
                441 patients aged over 18 years admitted between 12 June and 30 November 2000, with expected length of stay over 2 days and assessed as at low to moderate risk of developing pressure ulcers.
                Patients were randomly allocated to receive a sheepskin mattress overlay for the duration of their hospital stay (218 patients) or usual treatment, as determined by ward staff (referent group, 223 patients).
                Incidence rate and cumulative incidence of pressure ulcers, assessed daily throughout hospital stay.
                58 patients developed pressure ulcers (sheepskin group, 21; referent group, 37). Cumulative incidence risk was 9.6% in the sheepskin group (95% CI, 6.1%-14.3%) versus 16.6% in the referent group (95% CI, 12.0%-22.1%). Patients in the sheepskin group developed new pressure ulcers at a rate less than half that of referent patients (rate ratio, 0.42; 95% CI, 0.26-0.67).
                The Australian Medical Sheepskin is effective in reducing the incidence of pressure ulcers in general hospital inpatients at low to moderate risk of these ulcers. To assess the cost effectiveness of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers in patients admitted to hospital.
                Cost effectiveness analysis carried out alongside the pressure relieving support surfaces (PRESSURE) trial; a multicentre UK based pragmatic randomised controlled trial.
                11 hospitals in six UK NHS trusts.
                Intention to treat population comprising 1971 participants.
                Kaplan Meier estimates of restricted mean time to development of pressure ulcers and total costs for treatment in hospital.
                Alternating pressure mattresses were associated with lower overall costs (283.6 pounds sterling per patient on average, 95% confidence interval--377.59 pounds sterling to 976.79 pounds sterling) mainly due to reduced length of stay in hospital, and greater benefits (a delay in time to ulceration of 10.64 days on average,--24.40 to 3.09). The differences in health benefits and total costs for hospital stay between alternating pressure mattresses and alternating pressure overlays were not statistically significant; however, a cost effectiveness acceptability curve indicated that on average alternating pressure mattresses compared with alternating pressure overlays were associated with an 80% probability of being cost saving.
                Alternating pressure mattresses for the prevention of pressure ulcers are more likely to be cost effective and are more acceptable to patients than alternating pressure overlays. studies of the effectiveness of alternating pressure air mattresses (APAMs) for the prevention of pressure ulcers are scarce and in conflict.
                evaluating whether an APAM is more or equally effective as the standard prevention.
                randomised controlled trial. Setting and subjects: patients admitted to 19 surgical, internal, or geriatric wards in seven Belgian hospitals were included if they were in need of prevention of pressure ulcers. To define this need, two methods were used randomly: the Braden Scale or the presence of non-blanchable erythema (NBE).
                447 patients were randomised into either an experimental or a control group. In the experimental group, 222 patients were lying on an APAM (Alpha-X-Cell, Huntleigh Healthcare, UK). In the control group, 225 patients were lying on a visco-elastic foam mattress (Tempur, Tempur-World Inc., USA) in combination with turning every 4 hours. Both groups had identical sitting protocols.
                there was no significant difference in incidence of pressure ulcers (grade 2-4) between the experimental (15.6%) and control group (15.3%) (P = 1). There were significantly more heel pressure ulcers in the control group (P = 0.006). There was an interaction effect between the risk assessment method and preventive measures for the development of all pressure ulcers and sacral pressure ulcers.
                fewer patients developed heel pressure ulcers on an APAM. Patients identified as being in need of prevention based on the presence of NBE had a tendency to develop fewer pressure ulcers on an APAM. Patients identified as being in need of prevention, based on the Braden Scale, appeared to develop more sacral pressure ulcers on an APAM. Many devices are in use to prevent pressure ulcers, but from most little is known about their effects and costs. One such preventive device is the Australian Medical Sheepskin that has been proven effective in three randomized trials. In this study the costs and savings from the use of the Australian Medical Sheepskin were investigated from the perspective of a nursing home.
                An economic model was developed in which monetary costs and monetary savings in respect of the sheepskin were balanced against each other. The model was applied to a fictional (Dutch) nursing home with 100 beds for rehabilitation patients and a time horizon of one year. Input variables for the model consisted of investment costs for using the sheepskin (purchase and laundry), and savings through the prevented cases of pressure ulcers. The input values for the investment costs and for the effectiveness were empirically based on a trial with newly admitted rehabilitation patients from eight nursing homes. The input values for the costs of pressure ulcer treatment were estimated by means of four different approaches.
                Investment costs for using the Australian Medical Sheepskin were larger than the monetary savings obtained by preventing pressure ulcers. Use of the Australian Medical Sheepskin involves an additional cost of approximately 2 euro per patient per day. Preventing one case of a sacral pressure ulcer by means of the Australian Medical Sheepskin involves an investment of 2,974 euro when the sheepskin is given to all patients. When the sheepskin is selectively used for more critical patients only, the investment to prevent one case of sacral pressure ulcers decreases to 2,479 euro (pressure ulcer risk patients) or 1,847 euro (ADL-severely impaired patients). The factors with the strongest influence on the balance are the frequency of changing the sheepskin and the costs of washing related to this. The economic model was hampered by considerable uncertainty in the estimations of the costs of pressure ulcer treatment.
                From a nursing home perspective, the investment costs for use of the Australian Medical Sheepskin in newly admitted rehabilitation patients are larger than the monetary savings obtained by preventing pressure ulcers. To compare the effectiveness of a high-specification foam mattress (control) with a high-tech (Duo2, Hill Rom) alternating/continuous low-pressure mattress (treatment) in the prevention of pressure ulceration. The study also evaluated if there is a difference in performance between the two working modalities (alternating and continuous low pressure) of the high-tech mattress in a comparable sample of patients. MethoD: Thirty-three patients were observed for two weeks in the control group. In the treatment group, 86 patients were randomised to receive alternating low pressure and 84 continuous low pressure. Incidence of pressure ulcers in both arms was recorded. Student's t-test was used to compare all Braden scores, and the chi-square test and Fisher's exact test to evaluate differences between groups.
                There was a high difference in the number of new pressure ulcers in the control group when compared with the treatment group. There was no difference in performance between the alternating and continuous low-pressure modes. However, the sample size is too small to prove or disprove a statistically significant difference between the two modalities.
                The high-tech mattress was markedly more effective than the high-specification foam mattress in preventing the onset of pressure ulcers. Initial data suggest that the use of alternating or continuous low pressure made little or no difference to the results. This study assessed the clinical effectiveness of the Nimbus 3 alternating pressure mattress replacement system (APMRS) on pressure ulcer healing and comfort in subjects > or = 65 years, with at least a Grade 2 ulcer and some mobility problems. Twelve patients in a hospital setting were randomly allocated to the Nimbus 3 or another APMRS, and 20 residents in a nursing home setting to the Nimbus 3 or an alternating pressure mattress overlay. Wound surface area (WSA) (cm2) was recorded twice weekly and comfort once weekly. In the hospital setting, there were no significant differences between groups in the reduction in WSA per day. In the nursing home setting, though subjects on Nimbus 3 had significantly more pressure ulcers at baseline, there were no significant differences between groups in the reduction in WSA per day. Nimbus 3 was statistically more comfortable than control surfaces. The study's sample size has not shown the products were different with regard to clinical effectiveness. However, it might serve as a pilot for a larger, multi-centre RCT aimed at establishing the efficacy of a pressure-relieving (PR) device on pressure ulcer healing. The purpose of this study was to compare the incidence of pressure ulcers in 40 newly admitted at-risk (Braden Scale score < 18) skilled-nursing-facility residents, randomly assigned to Iris 3000 (Bio Clinic of Sunrise Medical Corp, Ontario, CA) foam mattress overlays (n = 20) or a MAXIFLOAT (BG Industries, Northridge, CA) foam mattress replacements (n = 20). Head-to-toe skin assessments were done 3 times weekly for a maximum of 21 days, using Bergstrom Skin Assessment Tool. Subjects on MAXIFLOAT had fewer pressure ulcers (chi 2[1, N = 40] = 5.013, p = .025) despite heavier body mass (t[35] = 2.60, p = .013) and more days on the surface (t[38] = 2.24, p = .03). MAXIFLOAT proved to be more effective in preventing pressure ulcers in an at-risk skilled-care population and was cost-effective. Research findings on efficacy, adequate feedback from nursing staff, residents, and ancillary staff regarding issues of patient comfort, ease of use, and cost are important factors in decision-making when considering product changes. In this experimental study, a 4-cm thermoactive viscoelastic foam overlay and a heating source on the operating room table was compared with the standard operating room table with a heating source for the effect on the postoperative pressure ulcer incidence in cardiac surgery patients.
                Pressure ulcer incidence in the cardiac surgery population is reported to be up to 29.5%. The prolonged compressive forces from lying on the operating room table are one source of pressure ulcer development in this population. Pressure-reducing devices on the operating room (OR)-table should reduce the patients' interface pressure and thus the hazard of skin breakdown.
                A randomized controlled trial was performed to test the effect of a 4-cm thermoactive viscoelastic foam overlay with a water-filled warming mattress on the OR-table (test OR-table) compared with the standard OR-table (a water-filled warming mattress, no pressure-reducing device) on the postoperative pressure ulcer incidence in cardiac surgery patients.
                The pressure ulcer classification system of the European Pressure Ulcer Advisory Panel (EPUAP) was used for pressure ulcer grading.
                The results show that patients lying on the 4-cm thermoactive viscoelastic foam overlay suffer slightly more pressure ulcer (17.6%) than patients on the standard OR-table without the foam overlay (11.1%). Because of the clinical relevance of the results, the randomized controlled trial was terminated after 175 patients at the interim analysis although the power calculation stated 350 patients.
                The combination of a 4-cm viscoelastic foam overlay and a warming source cannot be recommended for pressure ulcer prevention on the operating room table.
                Foam overlays are used to prevent pressure ulcers in patients. It is necessary to use such devices according to patient safety and use of resources.
People at high risk of developing pressure ulcers should use higher-specification foam mattresses rather than standard hospital foam mattresses. The relative merits of higher-specification constant low-pressure and alternating-pressure support surfaces for preventing pressure ulcers are unclear, but alternating-pressure mattresses may be more cost effective than alternating-pressure overlays in a UK context. Medical grade sheepskins are associated with a decrease in pressure ulcer development. Organisations might consider the use of some forms of pressure relief for high risk patients in the operating theatre.