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. A comparative study of an alternating air mattress for the prevention of pressure ulcers in surgical patients. Effect of visco-elastic foam mattresses on the development of pressure ulcers in patients with hip fractures. A randomized trial of low-air-loss beds for treatment of pressure ulcers. Randomised controlled trial to evaluate a new double-layer air-cell overlay for elderly patients requiring head elevation. Pressure ulcer prophylaxis in elderly patients using polyurethane foam or Jay wheelchair cushions. Comparative study of a foam mattress and a water mattress. Randomized clinical trial comparing 2 support surfaces: results of the Prevention of Pressure Ulcers Study. Randomized comparison trial of the RIK and the Nimbus 3 mattresses. Prevention of pressure ulcers in elderly nursing home residents: are special support surfaces the answer? Randomized controlled trial to determine the safety and efficacy of a multi-cell pulsating dynamic mattress system in the prevention of pressure ulcers in patients undergoing cardiovascular surgery. The role of support surfaces and patient attributes in preventing pressure ulcers in elderly patients. Clinical utility and cost-effectiveness of an air suspension bed in the prevention of pressure ulcers. A randomised controlled trial of two pressure-reducing surfaces. Profiling beds versus standard hospital beds: effects on pressure ulcer incidence outcomes. Randomised controlled trial of two pressure-relieving systems. A randomized control trial to evaluate pressure-reducing seat cushions for elderly wheelchair users. A comparison of two pressure-relieving devices on the prevention of heel pressure ulcers. [Prevention of heel pressure sores with a foam body-support device. A randomized controlled trial in a medical intensive care unit]. Effects of position and mattress overlay on sacral and heel pressures in a clinical population. Pressure ulcer prevention in intensive care - a randomised control trial of two pressure-relieving devices. Challenging the pressure sore paradigm. Special mattresses: effectiveness in preventing decubitus ulcers in chronic neurologic patients. Pressure sores and pressure-decreasing mattresses: controlled clinical trial. A sequential randomised controlled trial comparing a dry visco-elastic polymer pad and standard operating table mattress in the prevention of post-operative pressure sores. Evaluation of the effectiveness of two support surfaces following myocutaneous flap surgery. Air-fluidized beds or conventional therapy for pressure sores. A randomized trial. A clinical trial of a bead bed system for the prevention of pressure sores in elderly orthopaedic patients. Research comparing three heel ulcer-prevention devices. The role of alternating air and Silicore overlays in preventing decubitus ulcers. Seeking quality care for patients with pressure ulcers. The impact of pressure ulcer risk assessment on patient outcomes among hospitalised patients.
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. Research indicates that 8.5% of all patients undergoing surgical procedures for more than 3 hours develop pressure ulcers. In some types of surgery, incidence rates in excess of 25% have been reported. An 11-month study was conducted on the safety and efficacy of an experimental alternating air device in comparison with a tertiary care facility's conventional practice. A series of 217 patients undergoing surgical procedures scheduled for a minimum of 3 hours were enrolled. No ulcers developed in the experimental group and 11 ulcers developed in seven patients in the control group (8.75% incidence rate). Of the 11 ulcers, one was Stage I, four were Stage II, and six were unstageable secondary to eschar. The difference between the groups is significant at the P = 0.005 level. Individuals who developed ulcers had a length of stay approximately 7 days longer than the hospital average for comparable patients who did not develop ulcers. This study had three aims: to investigate if visco-elastic foam mattresses are more effective than standard hospital mattresses in reducing the incidence of pressure ulcers in patients with hip fractures; to compare pressure ulcer grade and location and documented nursing prevention and treatment interventions in patients using the two types of mattresses; to identify possible predictors of pressure ulcer development. Using a prospective randomised controlled trial design 101 patients (mean age: 84 years) were randomly allocated either a visco-elastic foam mattress or a standard mattress. There was no significant difference in the incidence of pressure ulcers between the two groups, but patients on standard mattresses tended to develop more severe pressure ulcers. Furthermore, according to the documentation, patients with grade I pressure ulcers who were allocated a standard mattress received more preventive interventions, which may have reduced the differences in outcomes between the two groups. The researchers concluded that the results support the use of the test mattress. Significant predictors of pressure ulcer development were long waiting times for surgery and low haemoglobin levels at hospital admission. To assess the effectiveness of low-air-loss beds for the treatment of pressure ulcers in nursing homes.
                Prospective, randomized, clinical trial.
                Three teaching nursing homes in Los Angeles, Calif.
                Eighty-four nursing home residents with trunk or trochanter pressure ulcers (Shea stage > or = 2).
                Subjects were randomly assigned to use either a low-air-loss bed (n = 43) or a 10-cm corrugated foam mattress (n = 41) throughout the healing of their ulcers.
                Ulcers were assessed twice weekly using surface area and two observational scales (median follow-up, 37.5 days; range, 4 to 571 days).
                Groups were similar with respect to demographics, medical variables, wound care, and early dropouts. Results indicate more than a threefold improvement in median rate of healing for low-air-loss beds compared with foam mattresses (9.0 vs 2.5 mm2/d; P = .0002). This finding was true for deep as well as superficial ulcers (deep ulcers, 9.9 vs 0.7 mm2/d; P = .02; superficial ulcers, 9.0 vs 3.2 mm2/d; P = .004). Cox regression models revealed that the bed, ulcer depth, and fecal continence had independent effects on healing. After controlling for fecal continence, the deep and superficial subgroups using low-air-loss beds remained 2.5 times more likely to heal in a given length of time compared with those using foam mattresses (combined cure probability ratio, 2.66; 95% confidence interval, 1.34 to 5.17; P < .004).
                Low-air-loss beds provide substantial improvement compared with foam mattresses despite other factors in pressure ulcer healing. A clinical investigation was conducted concerning the effects of a newly designed double-layer air-cell overlay in preventing the onset of pressure ulcers for patients with a Braden scale score of < or = 16, and who require a head-elevated position of 45 degrees or higher. A randomised controlled trial was undertaken involving 82 patients from a general hospital ward using one of the following three support surfaces: a double-layer air-cell overlay, a single-layer air-cell overlay or a standard hospital mattress. A significantly lower percentage of patients using the double-layer air-cell overlay developed pressure ulcers (3.4%) compared to 19.2% and 37.0% for those patients using the single-layer air-cell overlay and standard mattress respectively. Based on these findings, a double-layer air-cell overlay should be more effective in preventing the onset of pressure ulcers than either a single-layer air-cell overlay or a standard hospital mattress for subjects requiring head elevation. A significantly lower proportion of the patients in the Jay group (25%) experienced pressure ulcer formation during the three months of observation as compared to the foam group (41%). No statistically significant differences were found between groups on the location, severity, or healing duration of the pressure ulcers. Most lesions (65%) were limited to persistent erythema of intact skin, and healed in three to four weeks. Significantly higher proportions of patients in the Jay groups (7%) rejected their cushion because of discomfort as compared to foam (1%). The incidence of pressure ulcers was significantly higher among those patients who experienced peak interface pressures recorded at 60 mmHg or higher, had low Norton scores (< or = 11), or were malnourished. In order to determine the effectiveness of high-quality foam replacement mattresses in the treatment of pressure ulcers, one such mattress (TheraRest) was compared with a water mattress (Secutex). One hundred and twenty nursing home patients with pressure ulcers were randomised into two groups and nursed on one of the mattresses for four weeks. After four weeks, 45% of the patients using the foam mattress were completely healed, compared with 48.3% of those using the water mattress. This difference is not significant. Since high-quality foam mattresses are cheaper in the long term than water mattresses, and are easier for nursing staff to manage, it is suggested that these mattresses are preferable. To determine whether a viscoelastic polymer (energy absorbing) foam mattress was superior to a standard hospital mattress for pressure ulcer prevention and to analyze the cost-effectiveness in comparison with standard hospital mattresses.
                Unblinded, randomized, prospective trial.
                Elderly acute care, rehabilitation, and orthopedic wards at 3 hospitals in the United Kingdom.
                1168 patients at risk of developing pressure ulcers (Waterlow score, 15 to 20), with a median age of 83 years (25th to 75th percentile range, 79-87).
                Participants were allocated to either the experimental equipment (CONFOR-Med mattress/cushion combination) or a standard mattress/cushion combination; all were given standard nursing care. Pressure areas were observed daily.
                Development of nonblanching erythema.
                A significant decrease in the incidence of blanching erythema (26.3% to 19.9%; P =.004) and a nonsignificant decrease in the incidence of nonblanching erythema occurred in participants allocated to the experimental equipment. However, when the survival curve plots were analyzed at 7 days, both categories showed statistically significant decreases (P =.0015 and P =.042, respectively). Participants on standard equipment had a relative odds ratio of 1.36 (95% confidence interval [CI], 1.10-1.69) for developing blanching erythema or worse and 1.46 (95% CI, 0.90-1.82) for developing nonblanching erythema or worse. To prevent nonblanching erythema, the number needed to treat (NNT) was 41.9 (95% CI, -82.6-15.3). To prevent any erythema (blanching or nonblanching), the NNT was 11.5 (95% CI, 41.6-9.3). Participants with blanching or nonblanching erythema were significantly less mobile than participants with normal skin and more likely to have worsening mobility (P <.001). For participants with similar pressure ulcer status, mattress type was not associated with difference in mobility.
                Regardless of prevention routine, pressure ulcers occur. In this study, the experimental equipment showed statistical significance to standard equipment for prevention of blanching erythema; significance was not achieved for nonblanching erythema. Trend and survival analysis show that a larger study is required to determine whether this nonsignificant difference is genuine. A randomized comparison trial was carried out at Queen's Hospital, Burton-on-Trent, to compare patient outcomes on the RIK mattress (KCI) and the Nimbus 3 mattress (Huntleigh Healthcare). One hundred and fifty-eight patients, who were assessed to be at particular risk of development of pressure ulcers using the Waterlow score (85 on RIK mattress, 83 on Nimbus), completed the trial. There were no statistically significant differences in baseline parameters at recruitment or pressure ulcer progress. Lack of difference can be as useful as evidence of superiority. Other factors such as nursing interventions required accessible equipment, and costs are important when making equipment choices. For a significant proportion of patients, a static (RIK) mattress can be as effective as an active (Nimbus 3) mattress for management of pressure ulcers. This article describes a research study that compared the effectiveness of two pressure-reducing devices in a group of elderly nursing home residents. The results obtained revealed no significant differences between the two devices--an air-filled overlay and a gel mattress--in terms of pressure ulcer incidence, severity, and healing. Several factors contributed to these results and illustrate the problems encountered when preventing pressure ulcer development in a group of elderly, debilitated nursing home residents. These factors include ease of use of the pressure-reducing device, caregiver and facility characteristics, and critical patient variables. Until these variables are addressed, it is impossible for any device to be effective in preventing pressure ulcer development in nursing homes. The purpose of this study was to determine the efficacy and safety of a multi-cell pulsating dynamic mattress system in comparison with conventional management for the prevention of pressure ulcers in the operative and postoperative period in patients having cardiovascular surgery. The study was a single center, prospective, randomized, controlled trial. Patients who were having cardiovascular surgery for a duration of at least 4 hours were randomly assigned, prior to surgery, to dynamic mattress system or conventional management--both of which were initiated in the operating room and continued for up to 7 days postoperatively. Patients were assessed daily using a standardized scoring system. The results of the study showed that 198 patients in the dynamic pressure system (n = 98) or conventional management group (n = 100) were similar at baseline. A strong trend of decreased pressure ulcers existed in the dynamic pressure system group (n = 2) compared to the conventional management group (n = 7). The study concluded that a multi-cell pulsating dynamic mattress system is safe and mitigates risks for and decreases incidence of pressure ulcers in patients who undergo cardiovascular surgery. Nurses caring for elderly patients often need to select support surfaces that reduce the likelihood of pressure ulcers, but there is little information about the effectiveness of different support surfaces. This randomized trial compared two support surfaces and investigated patient attributes related to the risk of developing a pressure ulcer. Eighty-four elderly patients were nursed on a convoluted or solid foam overlay and assessed three times a week for pressure ulcers. Stepwise Cox proportional hazards regression revealed a statistically significant relationship between the risk of developing a pressure ulcer and the variables mobility and type of support surface. To determine, in critically ill patients at risk, both the clinical utility and cost-effectiveness of using an air suspension bed in the prevention of pressure ulcers.
                Randomized, parallel group, controlled clinical trial with accompanying cost-effectiveness analysis.
                30-bed multidisciplinary intensive care unit.
                100 consecutive patients at risk for the development of pressure ulcers randomly assigned to receive treatment on either an air suspension bed or a standard intensive care unit bed. Patients considered at risk were those at least 17 years of age with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 15 who had an expected intensive care unit stay of at least 3 days.
                The development of pressure ulcers by site and severity and the costs associated with each of the two programs.
                The air suspension bed was associated with fewer patients developing single, multiple, or severe pressure ulcers. In patients at risk, the use of an air suspension bed in the prevention of pressure ulcers was a cost-effective therapy.
                Despite intense nursing care, pressure ulcers are more prevalent in the critically ill patient population than in the general hospital population. Air suspension therapy provides a clinically effective means of preventing pressure ulcers in these patients. In patients at risk, air suspension therapy was a cost-effective means of managing pressure ulcers compared with the standard hospital bed. This randomised controlled trial of two dry-flotation pressure-reducing surfaces evaluates pressure sore incidence, patient comfort and the appropriate use of equipment in 100 orthopaedic patients. The trial involved five full Roho mattresses, five Sofflex mattresses and 10 Roho Quatro cushions to be used to complement the beds. Given the low rate of pressure sore incidence in this high-risk group it is not possible to determine whether there is any difference in effectiveness between the two mattresses. Both appear to provide similar levels of comfort, with the majority of patients finding them either comfortable or very comfortable. The initial setting of the equipment was, however, unsatisfactory. Most standard hospital beds are flat based with a pull-out backrest, resulting in a tendency for the patient to slide down the bed. This study aimed to compare the outcome for patients at high risk of developing pressure ulcers nursed on either this type of bed or an electrically operated, multi-sectioned profiling bed. A total of 100 patients were randomly assigned either to the profiling bed with a pressure-reducing foam mattress (experimental group) or a flat-based bed with an appropriate pressure-redistributing mattress (control group) for a maximum of 10 days. Risk status and pressure damage were assessed daily. Both a patient and a nurse questionnaire were completed. Data from 70 patients who participated in the study for five days or more were included in the analysis. Pressure ulcer incidence was 0% in both groups. All patients (35) in the experimental group were able to maintain a sitting position compared with only 12/35 in the control group (p = 0.0001). While the questionnaire results suggest there were significant differences in postural control and ease of transfer between patients in the two groups, it was not possible to map this to pressure ulcer formation. Poor recruitment into the study was due to the 'blocking' of electric beds by heavily dependent patients who did not meet the inclusion criteria, precluding a significant result in terms of pressure ulcer outcomes. This nurse-led use of the profiling beds was examined alongside the main study to investigate why they were allocated in this way. The primary objective of this randomised controlled trial was to determine whether there were significant differences between two pressure-relieving systems. A secondary aim was to investigate whether the availability of extra pressure-relieving equipment would reduce the incidence of ulcers in an acute hospital setting. A total of 141 patients in a care-of-the-elderly unit, who were assessed to have a high risk of developing pressure ulcers using the Waterlow score, were recruited; 70 were nursed using Huntleigh Nimbus 3 in conjunction with the Aura cushion (Group A), and 71 using the Pegasus Cairwave Therapy System in conjunction with the Proactive 2 Seating cushion (Group B). The main outcome measure was visual assessment, supported by a photographic record. There were three main findings: for non-heel ulcers and overall improvement, there was no statistically significant difference between the two products tested; for heel ulcers there was a significant difference (P = 0.019) with more patients healing in Group A than in Group B. The average length of stay of patients who completed the trial was 21.6 days (Group A) and 21.7 days (Group B) for patients completing a live (range 1-121 days) and for patients who died 29.7 days (Group A) and 24.3 days (Group B). Routine monitoring showed that, before the trial, the incidence of hospital-acquired pressure ulcers (Torrance grade 2+) was 0.2%; during the trial, this dropped to 0.13%. The study showed differences in the efficacy of different mattress products; with a sufficiently large study, it is possible to demonstrate statistically significant results. Provision of extra pressure-relieving equipment can reduce the incidence of pressure ulcers but may not influence length of stay. To determine if the use of pressure-reducing wheelchair cushions for elderly nursing home resident wheelchair users who are at high risk for developing sitting-acquired pressure ulcers would result in a lower incidence rate of pressure ulcers, a greater number of days until ulceration, and lower peak interface pressures compared with the use of convoluted foam cushions over a 12-month period. To determine the feasibility of conducting a subsequent full-scale definitive trial to evaluate the use of pressure-reducing seat cushions for elderly nursing home resident wheelchair users.
                Randomized control trial
                2200-bed skilled nursing facilities (1 suburban and 1 urban academic medical center)
                32 male and female at-risk nursing home residents who were wheelchair users > or = 65 years of age. Participants had Braden Scale scores < or = 18, Braden Activity and Mobilitysubscale scores < or = 5, no sitting surface pressure ulcers, and a daily wheelchair sitting tolerance of more than 6 hours. All met criteria for using the ETAC Twin wheelchair.
                Seating evaluation with pressure-mapping and subsequent seating prescription. Subjects were assigned to either a foam (n=17) or pressure-reducing cushion (n=15) group and weekly assessments of skin and pressure ulcer risk were made.
                Incidence of pressure ulcers, days to ulceration, and peak interface pressure.
                At a 95% confidence interval, a 2-tailed analysis showed no differences between the FOAM and pressure-reducing cushion groups for pressure ulcer incidence, total days to pressure ulcer, or initial peak interface pressure. Pressure-reducing cushions were more effective in preventing sitting-acquired (ischial) pressure ulcers (P<.005). Higher interface pressures were associated with a higher incidence of pressure ulcers (P<.001).
                A definitive randomized control multicenter cushion trial is feasible with a sample size of 50 to 100 per study group. In the definitive trial, the definition of sitting-acquired pressure ulcers should be limited to lesions occurring over the ischial tuberosities. The effectiveness of hospital pillows versus a commercial heel elevation device (the Foot Waffle [EHOB incorporated]) in preventing heel pressure ulcers was examined using an experimental balanced factorial design with repeated measures on 52 patients (ages 27 to 90) in randomized groups. Heel interface pressures were taken with patients in supine and right lateral tilt positions. Logistic regression demonstrated a statistically significant difference between interface pressures on left and right heels (p = .004) and a trend toward significance between the pillow and Foot Waffle (p = .069). The Generalized Estimating Equations (GEE) method revealed the Foot Waffle was four times more likely not to suspend the heel off the bed than the pillow, and the left heel was four-and-a-half times more likely to have higher interface pressures than the right. There was no significant difference between groups in incidence of lower-extremity pressure ulcers, but patients using the Foot Waffle developed pressure ulcers significantly sooner (10 days versus 13 days for the pillow). Heels require additional protection beyond the use of specially beds and mattress overlays. In order to provide continuous heel suspension, clinicians must consider proper fit, turning schedules, patient position, patient activity, and presence of additional equipment when selecting heel protection products. This study illustrates how difficult it is to control for all these factors when doing clinical research. Note: This study was done with a Foot Waffle model that has since been redesigned. No research is available on the new model. To assess in a prospective controlled study the efficacy and safety of a specific foam body-support device designed as to prevent heel pressure ulcers.
                A randomization table was used to allocate 70 patients into 2 groups. The control group was treated with our standard pressure sore prevention protocol (half-seated position, water-mattress and preventive massages 6 times a day); the experimental group was treated with the same standard protocol as well as with the foam body-support device being evaluated. Patients were included if their Waterlow score was >10, indicating a high risk of developing pressure ulcers and if they had no skin lesion on the heels. Foam devices, covered with jersey, were constructed for the legs and allowed the heels to be free of any contact with the bed; another foam block was arranged perpendicularly to the first, in contact with the soles, to prevent ankles from assuming an equinus position (to prevent a dropfoot condition). The principal criterion for efficacy was the number of irreversible skin lesions on the heel (that is, beyond the stage of blanching hyperemia, reversible after finger pressure); these lesions were assessed every day until the end of the study (up to 30 days).
                The number of irreversible heel pressure ulcers was lower in the experimental (3 patients, 8.6%) than in the control group (19 patients, 55.4%) (p<0.0001). Mean time without any pressure ulcer was higher in the experimental group (5.6 days, compared with 2.8 days, p=0.01). The groups did not differ in the number of pressure sores on the sacrum and leg.
                An anatomical foam body-support is effective in preventing heel pressure ulcers in patients on a medical intensive care unit and is well tolerated. A comparison of pressure reducing properties of alternating air, static air, and water mattress overlays was conducted with 57 patients in a surgical intensive care unit. Sacral and heel pressures in both recumbent and semi-Fowler's positions were tested for each surface using a repeated measures design. Mean pressures for the alternating air mattress were significantly higher than pressures with other surfaces, regardless of position or site. There were significant main effects for position and site, with higher pressures in the semi-Fowler's position and at the sacral site. A significant interaction between surface, site, and position was found. Pressure sores developed in eight patients, but the incidence was not significantly different across groups. A pressure measuring device constructed from available clinical materials proved to be both sensitive and reliable. The findings suggest alternating air overlays should be avoided, and that positioning and periodic position change to reduce sacral pressures for patients requiring prolonged upper body elevation is important. Pressure sores are a potential complication of intensive care. Modern methods of pressure sore prevention centre around the use of pressure-relieving devices. Few studies exist that confirm the effectiveness of these devices. This study evaluates the effectiveness of two devices, the Hill-Rom Duo mattress and the KCI TheraPulse. High-risk patients were randomly assigned to receive one of two devices. We excluded those patients who had pressure sores upon admission. Those patients that did develop a pressure sore had their wound digitally photographed and graded by two independent tissue viability nurses. Sixty-two patients were included (30 TheraPulse, 32 Duo. Nine developed a pressure sore (6 Duo, 3 TheraPulse). No statistical differences between the two devices could be found. The longer a patient was nursed on a device, the greater the risk of pressure sore development. Despite the use of these devices, pressure sores can still develop in the Intensive Care patient population. This study determines the effectiveness of a new low-unit-cost support system in patients at very high risk of developing pressure sores. In a prospective randomised controlled trial, a low-pressure inflatable mattress and cushion system (Repose) was compared to a dynamic support mattress (Nimbus II) used in conjunction with an alternating-pressure cushion (Alpha TranCell) in 80 patients with fractured neck of femur and high scores on a pressure sore risk assessment scale. All patients received best standard care, including turning at regular intervals. Skin condition was assessed in 17 locations on admission, preoperatively, and seven and 14 days postoperatively. No difference was found between the groups in skin condition or the occurrence and severity of pressure sores at any time point. Thirty-two chronic neurologic patients between 19 and 60 years of age were randomly assigned, for a period of three months, to either an alternating air mattress or a silicore mattress to test the preventive qualities of special mattresses in the occurrence of decubitus ulcers. The two groups were comparable on the variables of age, weight, diagnoses, history of disease process, history of being wheelchair bound, history of previous pressures, and mean scores on Norton's scale of risk, which is based on the subject's physical condition, mental alertness, ambulation, mobility and incontinence. No significant differences were observed in the preventive qualities of the two types of special mattresses in terms of the incidence, location, severity, or healing duration of the subjects' decubitus ulcers. Improved studies of common special mattresses are suggested. Pressure sores are a problem, especially in elderly patients. Our study was designed to determine the effectiveness in pressure-sore prevention of a new interface-pressure decreasing mattress. In a prospective randomised controlled clinical trial we tested the Comfortex DeCube mattress (Comfortex, Winona, USA) against our standard hospital mattress in 44 patients with femoral-neck fracture and concomitant high pressure-sore risk score. In addition both groups were treated according to the Dutch consensus protocol for the prevention of pressure sores. On admission and 1 and 2 weeks after admission, pressure sores were graded. The two groups were similar in patient characteristics and pressure-sore risk factors. At 1 week, 25% of the patients nursed on the DeCube mattress and 64% of the patients nursed on the standard mattress had clinically relevant pressure sores (grade 2 or more). At 2 weeks the figures were 24% and 68%, respectively. The maximum score over the several body regions of the pressure-sore grading, measured on a 5-point sale, was significantly different in favour of the DeCube mattress at 1 week (p = 0.0043) and 2 weeks (p = 0.0067) postoperatively. We show that the occurrence of pressure sores and their severity can be significantly reduced when patients at risk are nursed on an interface-pressure decreasing mattress. Four hundred and forty-six general, vascular and gynaecological surgical patients were recruited to a two centre, double triangular sequential randomised controlled trial to compare the post-operative pressure sore incidence in patients positioned on the standard operating table mattress with those positioned on the dry visco-elastic polymer pad (Action Products Inc.). Two hundred and twenty two patients were randomised to the experimental group and 224 to the standard mattress. The main endpoint failure rate (a pressure sore) was found to be 11% (22/205) for patients allocated to the dry visco-elastic polymer pad and 20% (43/211) for patients allocated to the standard operating table mattress. There was a significant reduction in the odds of developing a pressure sore on the dry visco-elastic polymer pad as compared to the standard, [symbol see text] = 0.46 with 95% confidence interval of (0.26, 0.82), P = 0.010. The adjusted point estimates of the probability of developing a pressure sore on the dry visco-elastic polymer pad and the standard operating table mattress were 0.11 and 0.21 respectively. Recurrence of pressure ulcers is a serious problem following myocutaneous flap surgery and can lead to prolonged and expensive hospitalization. One of the most important aspects of patient care after surgery is the monitoring of reduced pressure in the area of the flap. Usually reducing pressure requires an expensive high-tech support surface. The purpose of this study was to evaluate the effectiveness of a less expensive support surface. There were 12 patients involved in a clinical trial that lasted 14 days and compared the effectiveness of the ROHO dry-floatation mattress to that of the Clinitron bed. Findings indicated that post-operative patients were effectively treated on either support surface. To compare the effectiveness and adverse effects of air-fluidized beds and conventional therapy for patients with pressure sores.
                Randomized trial with both masked and unmasked comparisons of outcome after a median follow-up of 13 days (range, 4 to 77 days).
                Urban, academic referral, and primary care medical center.
                Of 140 potentially eligible hospitalized patients with pressure sores, 72 consented to randomization; 65 (90%) completed the study.
                Thirty-one patients on air-fluidized beds (Clinitron Therapy, Support Systems International, Inc., Charleston, South Carolina) repositioned every 4 hours from 0700h to 2300h without use of other antipressure devices. Thirty-four patients on conventional therapy used an alternating air-mattress covered by a foam pad (Lapidus Air Float System, American Pharmaceal Company, Cincinnati, Ohio) on a regular hospital bed; were repositioned every 2 hours; and had elbow or heel pads as needed. Topical therapy was standardized for both groups.
                Pressure sores showed a median decrease in total surface area (-1.2 cm2) on air-fluidized beds, but showed a median increase (+ 0.5 cm2) on conventional therapy; 95% confidence interval (CI) for the difference between medians, -9.2 to -0.6 cm2 (p = 0.01). Improvement, as assessed from serial color photographs by investigators masked to treatment group, occurred in 71% and 47%, respectively; 95% CI for the difference, 1% to 47% (p = 0.05). For pressure sores 7.8 cm2 or greater, outcome differences between air-fluidized beds and conventional therapy were greater: median total surface area change was -5.3 and +4.0 cm2, respectively; 95% CI for the difference, -42.2 to -3.2 cm2 (p = 0.01). Improvement rates were 62% and 29% respectively; 95% CI for difference, 1% to 65% (p = 0.05). After adjusting for other factors associated with sore outcome, the estimated relative odds of showing improvement with air-fluidized beds were 5.6-fold (95% CI, 1.4 to 21.7) greater than with conventional therapy (p = 0.01). No significant increase in adverse effects was seen with air-fluidized beds.
                Our findings suggest that air-fluidized beds are more effective than conventional therapy, particularly for large pressure sores. Studies are needed to determine the effectiveness of air-fluidized beds in long-term care settings. This paper summarizes the results of the trial of the Beaufort Bead Bed system designed to reduce the incidence and severity of pressure sores. Elderly orthopaedic admissions were allocated alternately to the Beaufort system and to the usual trolley, table and bed surfaces, and followed from admission to hospital until separation. The incidence of pressure sores was 15.6% in the 32 'trial' patients, which was significantly less than the 48.8% in the 43 'control' patients, as was the mean maximum diameter of the pressure sores incurred: 6.4 mm for the 'trials' as against 29.5 mm for the 'controls'. In particular the trial group were free from pressure lesions to the heel, which affected 32.6% of the control group. The groups were well matched on a variety of criteria on admission, and we conclude that the Beaufort system successfully reduces the incidence and severity of pressure sores for elderly orthopaedic patients. The system--renamed recently the 'Neumark-Macclesfield Support System'--is now in regular and satisfactory use. To compare 3 pressure-reduction devices for effectiveness in prevention of heel ulcers in moderate-risk to high-risk patients.
                A prospective quasi-experimental 3-group design was used.
                A sample of 338 "moderate-risk to high-risk" adult inpatients, ages 18 to 97, at 2 medical centers in South Texas were studied.
                The Braden Scale for Pressure Ulcer Risk and investigator-developed history and skin assessment tools were used.
                Subjects were randomly assigned to the High-Cushion Kodel Heel Protector (bunny boot), Egg Crate Heel Lift Positioner (egg crate), or EHOB Foot Waffle Air Cushion (foot waffle). Data are demographics, Braden scores, comorbidities, skin assessments, lengths of stay, and costs of devices. Analyses were Chi-square, analysis of variance, and regression.
                Of 240 subjects with complete data, 77 (32%) were assigned to the bunny boot group, 87 (36.3%) to the egg crate, and 76 (31.7%) to the foot waffle. Twelve ulcers developed in 240 subjects (5% incidence). Six subjects had only 1 foot. Eleven ulcers were Stage I (nonblanchable erythema), and 1 was Stage II (partial thickness). Overall incidence was 3.9% for the bunny boot, 4.6% for the egg crate, and 6.6% for the foot waffle (not significantly different among groups). The bunny boot with pillows was most cost effective (F[3], N = 240) = 1.342, p <or= .001).
                In this study, the bunny boot was as effective as higher-tech devices. The results, however, were confounded by nurses adding pillows to the bunny boot group. Patients with chronic neurological diseases who were at high risk of decubitus ulcers were randomly assigned to alternating air on silicore mattress overlays for a period of 3 months. Of 148 subjects who completed the trial, more than 50% in each group developed one or more ulcers. No statistically significant differences between groups were found in the incidence, severity, healing duration or the location of the ulcers; with the exception of a significant difference (p less than 0.001) in the categorical location of the trochanters. Improving quality care for patients with pressure ulcers resulted in a two-year intensive effort to educate staff, keep morale high, standardize care plans by stage of ulcer, and participate in a comparison study of two support surfaces (Thera-Pulse, Kinetic Concepts and Geo-Matt, SpanAmerica). When all pressure ulcers were considered, the analysis of covariance revealed no statistically significant difference in the healing of pressure ulcers with respect to type of support surface used (F[1, 78] = 0.35, p > .05). For patients with stage III and IV pressure ulcers, the proportion of patients improving more than 10cm2 was higher in the air-suspension group. There was relatively little difference in the Stage II ulcer patients. To determine whether use of a risk assessment scale reduces nosocomial pressure ulcers.
                There is contradictory evidence concerning the validity of risk assessment scales. The interaction of education, clinical judgement and use of risk assessment scales has not been fully explored. It is not known which of these is most important, nor whether combining them results in better patient care.
                Pretest-posttest comparison.
                A risk assessment scale namely the Braden was implemented in a group of wards after appropriate education and training of staff in addition to mandatory wound care study days. Another group of staff received the same education programme but did not implement the risk assessment scale and a third group carried on with mandatory study days only.
                Nosocomial Pressure Ulcer was reduced in all three groups, but the group that implemented the risk assessment scale showed no significant additional improvement. Allowing for age, gender, medical speciality, level of risk and other factors did not explain this lack of improvement. Clinical judgement seemed to be used by nurses to identify patients at high risk to implement appropriate risk reduction strategies such as use of pressure relieving beds. Clinical judgement was not significantly different from the risk assessment scale score in terms of risk evaluation.
                It is questioned whether the routine use of a risk assessment scale is useful in reducing nosocomial pressure ulcer. It is suggested clinical judgement is as effective as a risk assessment scale in terms of assessing risk (though neither show good sensitivity and specificity) and determining appropriate care.
                Clinical judgement may be as effective as employing a risk assessment scale to assess the risk of pressure ulcers. If this were true it would be simpler and release nursing time for other tasks.
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.