Randomised controlled trial of two pressure-relieving systems. The effects of non-thermal pulsed electromagnetic energy on wound healing of pressure ulcers in spinal cord-injured patients: a randomized, double-blind study. Using telehealth interventions to prevent pressure ulcers in newly injured spinal cord injury patients post-discharge. Results from a pilot study. Prevention of pressure ulcers in elderly nursing home residents: are special support surfaces the answer? A portable pulsed electromagnetic field (PEMF) device to enhance healing of recalcitrant venous ulcers: a double-blind, placebo-controlled clinical trial. The role of support surfaces and patient attributes in preventing pressure ulcers in elderly patients. Pressure ulcer prevention in intensive care - a randomised control trial of two pressure-relieving devices. Clinical utility and cost-effectiveness of an air suspension bed in the prevention of pressure ulcers. A randomized trial of low-air-loss beds for treatment of pressure ulcers.
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. The objective of this randomized, double-blind study was to determine if non-thermal pulsed electromagnetic energy treatment significantly increases the healing rate of pressure ulcers in patients with spinal cord injuries. Subjects included volunteers admitted to a Veteran's Administration Hospital in New York over a 2 year period and consisted of 30 male spinal cord-injured patients, 20 with Stage II and 10 with Stage III pressure ulcers. Subjects were given non-thermal pulsed high-frequency electromagnetic energy treatment for 30 minutes twice daily for 12 weeks or until healed. The percentage of pressure ulcers healed was measured at one week. Of the 20 patients with Stage II pressure ulcers, the active group had a significantly increased rate of healing with a greater percentage of the ulcer healed at one week than the control group. After controlling for the baseline status of the pressure ulcer, active treatment was independently associated with a significantly shorter median time to complete healing of the ulcer. Stage III pressure ulcers healed faster in the treatment group but the sample size was limited. For spinal cord-injured men with Stage II pressure ulcers, active non-thermal pulsed electromagnetic energy treatment significantly improved healing. To determine which of three approaches to care produces the lowest incidence of pressure ulcers, promotes the most effective care of sores that develop, and leads to the fewest hospitalizations in newly injured patients with spinal cord injury after discharge.
                Spinal cord injury patients (n = 12) were recruited for a telehealth intervention after initial injury, and matched cases were recruited for telephone counseling and standard care groups. Patients were monitored for 6-8 months after discharge.
                The video group had the greatest number of reported and identified pressure ulcers. Differences in health care utilization between the video and telephone telehealth groups were small. The standard care group reported the lowest number of pressure ulcers and lowest frequency of health care utilization. Substantial differences existed in employment rates before and after injury. The video group had the lowest pre-injury rate of employment and the highest post-injury rate of employment.
                Tracking pressure ulcer incidence, particularly stage I sores, is difficult. Self-report is likely to lead to substantial underreporting. Similarly, self-report on health care utilization over extended periods may lead to undercounting of encounters. Telehealth interventions appear to improve ulcer tracking and management of all ulcer occurrences. Video interventions may affect outcomes, such as employment rates, which are not conventionally measured. 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. A prospective, randomized, double-blind, placebo-controlled multicentre study assessed the clinical efficacy and safety of pulsed electromagnetic limb ulcer therapy (PELUT) in the healing of recalcitrant, predominantly venous leg ulcers. The portable device was used at home for 3 h daily during this 8-week clinical trial as an adjunct to a wound dressing. Wound surface area, ulcer depth and pain intensity were assessed at weeks 0, 4 and 8. At week 8 the active group had a 47.7% decrease in wound surface area vs. a 42.3% increase for placebo (P < 0.0002). Investigators' global evaluations indicated that 50% of the ulcers in the active group healed or markedly improved vs. 0% in the placebo group, and 0% of the active group worsened vs. 54% of the placebo group (P < 0.001). Significant decreases in wound depth (P < 0.04) and pain intensity (P < 0.04) favouring the active group were seen. Patients whose ulcers improved significantly after 8 weeks were permitted to continue double-blind therapy for an additional 4 weeks. Eleven active and one placebo patient continued therapy until week 12, with the active treatment group continuing to show improvement. There were no reports of adverse events attributable to this device. We conclude that the PELUT device is a safe and effective adjunct to non-surgical therapy for recalcitrant venous leg ulcers. 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. 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. 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. 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.
The results provide no strong evidence of benefit in using EMT to treat pressure ulcers. However, the possibility of a beneficial or harmful effect cannot be ruled out because there were only two included trials, both with methodological limitations and small numbers of participants. Further research is recommended.