A clinical evaluation of the Nimbus 3 alternating pressure mattress replacement system. Comparative study of a foam mattress and a water mattress. Seeking quality care for patients with pressure ulcers. Randomised controlled trial of two pressure-relieving systems. Randomized comparison trial of the RIK and the Nimbus 3 mattresses. The cost of home air-fluidized therapy for pressure sores. A randomized controlled trial. A randomized trial of low-air-loss beds for treatment of pressure ulcers. Pressure ulcers: one bed or another? Profiling beds versus standard hospital beds: effects on pressure ulcer incidence outcomes. Air-fluidized beds or conventional therapy for pressure sores. A randomized trial. Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis.
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. 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. 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. 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. 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. Recurrent pressures sores are a serious problem that often cause chronically ill patients to be hospitalized. We hypothesized that home air-fluidized bed therapy may be a safe and effective way to treat these patients, thus avoiding the costs of hospitalization.
                One hundred twelve patients with 3rd or 4th stage pressure sores were randomly assigned to 36 weeks of either (1) home air-fluidized bed therapy that included the services of a visiting nurse specialist as long as the patient had 3rd or 4th stage sores, or (2) conventional therapy.
                Compared with patients in the control group, patients receiving air-fluidized bed therapy spent fewer days in the hospital (11.4 days vs 25.5 days, P less than .01) and used fewer total inpatient resources, as reflected both in charges ($13,263 vs $25,736, P less than .05) and in Medicare DRG and physician payments ($6,646 vs $12,131, P less than .05). Total resources used (inpatient and outpatient) were lower for patients treated with air-fluidized bed therapy, but the difference was not statistically significant. Clinical outcomes were similar.
                Home air-fluidized bed therapy is safe, reduces hospitalizations, is no more costly than alternative therapy, and allows the patients to receive their needed care in a more desirable, nonhospital setting. 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. nan 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. 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. 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.
There is no conclusive evidence about the superiority of any support surface for the treatment of existing pressure ulcers. Methodological issues included variations in outcomes measured, sample sizes and comparison groups. Many studies had small sample sizes and often there was inadequate description of the intervention, standard care and co-interventions. Individual study results were often inadequately reported, with failure to report variance data common, thus hindering the calculation of mean differences. Some studies did not report P values when reporting on differences in outcomes. In addition, the age of some trials (some being 20 years old), means that other technologies may have superseded those investigated. 
Further and rigorous studies are required to address these concerns and to improve the evidence base before firm conclusions can be drawn about the most effective support surfaces to treat pressure ulcers.