Primary studies related to this topic

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A new pressure‐relieving mattress overlay.

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Journal European Wound Management Association Journal
Year 2013

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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Multi-stage versus single-stage inflation and deflation cycle for alternating low pressure air mattresses to prevent pressure ulcers in hospitalised patients: A randomised-controlled clinical trial.

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Journal International journal of nursing studies
Year 2012
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This article is included in 3 Systematic reviews Systematic reviews (3 references)

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Abstract: INTRODUCTION: The duration and the amount of pressure and shear must be reduced in order to minimize the risk of pressure ulcer development. Alternating low pressure air mattresses with multi-stage inflation and deflation cycle of the air cells have been developed to relieve pressure by sequentially inflating and deflating the air cells. Evidence about the effectiveness of this type of mattress in clinical practice is lacking. AIM: This study aimed to compare the effectiveness of an alternating low pressure air mattress that has a standard single-stage inflation and deflation cycle of the air cells with an alternating low pressure air mattress with multi-stage inflation and deflation cycle of the air cells. Methods and materials: A randomised controlled trial was performed in a convenience sample of 25 wards in five hospitals in Belgium. In total, 610 patients were included and randomly assigned to the experimental group (n =298) or the control group (n =312). In the experimental group, patients were allocated to an alternating low pressure air mattress with multi-stage inflation and deflation cycle of the air cells. In the control group, patients were allocated to an alternating low pressure air mattress with a standard single-stage inflation and deflation cycle of the air cells. The outcome was defined as cumulative pressure ulcer incidence (Grade II–IV). An intention-to-treat analysis was performed. RESULTS: There was no significant difference in cumulative pressure ulcer incidence (Grade II–IV) between both groups (Exp.=5.7%, Contr.=5.8%, p =0.97). When patients developed a pressure ulcer, the median time was 5.0days in the experimental group (IQR=3.0–8.5) and 8.0days in the control group (IQR=3.0–8.5) (Mann–Whitney U-test=113, p =0.182). The probability to remain pressure ulcer free during the observation period in this trial did not differ significantly between the experimental group and the control group (log-rank χ <sup>2</sup> =0.013, df=1, p =0.911). CONCLUSION: An alternating low pressure air mattress with multi-stage inflation and deflation of the air cells does not result in a significantly lower pressure ulcer incidence compared to an alternating low pressure air mattress with a standard single-stage inflation and deflation cycle of the air cells. Both alternating mattress types are equally effective to prevent pressure ulcer development.

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Cost effectiveness of an air-inflated static overlay for pressure ulcer prevention: a randomized, controlled trial.

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Authors Vermette S , Reeves I , Lemaire J
Journal Wounds : a compendium of clinical research and practice
Year 2012
Links Pubmed

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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UNLABELLED:  Numerous pressure-relieving surfaces of varying costs are available for the prevention of pressure ulcers. There is insufficient evidence to draw conclusions regarding the efficacy or merits of using more expensive technologies. The purpose of this unblinded, randomized, prospective study was to compare the clinical and the cost effectiveness of an inflated overlay with rented, pressure-relieving surfaces for the prevention of pressure ulcers. METHODS: Patients in a 257-bed acute care facility were included if they had a Braden score of ≤ 14, had no skin lesion(s), were ≥ 18 years, weighed < 300 lb, and submitted signed consent. One hundred, ten patients (110) were randomized into a control group using either a microfluid static overlay (MSO) or a low-air-loss dynamic mattress (LALDM) with pulsation (n = 55) or into an experimental group using an inflated static overlay (ISO) (n = 55). Both groups had identical positioning protocols. No statistically significant differences were noted between the 2 groups with regard to age, gender, weight, or Braden scale score. Head-to-toe assessments were performed 3 times a week for a maximum of 14 days to deter- mine presence of pressure ulcers and comfort; Fisher's exact and chi- squared tests were used to assess categorical data, and unpaired t-test and Mann-Whitney statistic tests were used to compare continuous variables. Comparative cost of support surface use was determined at the end of the study. RESULTS: In the control group, 50 patients used an MSO and 5 patients used an LALDM; in the experimental group, 55 patients used an ISO. No significant difference in pressure ulcer incidence was found between the control (n = 6) and experimental groups (n = 2) (11% versus 4%, respectively; P = 0.2706), and there was no significant difference in comfort (90% versus 85%; P = 0.7129). However, a significant difference was noted in total cost ($13,606 CAD versus $3,364 CAD, P ≤ 0.001); the ISO was less expensive. CONCLUSION: The use of an ISO offers a cost-effective option for the prevention of pressure ulcers in a moderate to very high-risk population. .

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Pressure relief, cold foam or static air? A single center, prospective, controlled randomized clinical trial in a dutch nursing home.

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Journal Journal of tissue viability
Year 2011
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This article is included in 4 Systematic reviews Systematic reviews (4 references)

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Abstract: OBJECTIVE: At present, the evidence regarding the type of mattress that is the best for preventing pressure ulcers is not convincing. In a single center, prospective, controlled trial we compared a static air overlay mattress (no electric pump needed) on top of a cold foam mattress with a cold foam mattress alone on pressure ulcer incidence in nursing home residents. METHODS: 83 Patients were included in the study with a score lower than 12 points on the Norton scale and no pressure ulcer at the start of the study. 42 Patients received a cold foam mattress and 41 patients received a static air overlay on top of that cold foam mattress. Out of bed we standardized the pressure reduction in sitting position by using a static air cushion in both groups. Patients were checked weekly in both groups for pressure ulcers. Only when there were signs of developing a pressure ulcer grade 2 or higher, repositioning by our nursing home pressure ulcer protocol (PU protocol) was put into practice. RESULTS: Seven patients (17.1%) on a cold foam mattress and two (4.8%) on a static air mattress developed a pressure ulcer grade 2 or more. There was no difference regarding pressure ulcer incidence between patients with a high risk (Norton 5–8) and patients with a medium risk (Norton 9-12). In 5 out of 7 patients who developed a pressure ulcer on a foam mattress the ulcers showed no healing using our PU protocol. In the static air group all pressure ulcers healed by regular treatment according to our PU protocol. CONCLUSIONS: In this study, static air overlay mattresses provided a better prevention than cold foam mattresses alone (4.8% versus 17.1%). The Norton scores of the patients in both groups did not change during the 6 month trial period. Our decision to use repositioning only when there were signs of a pressure ulcer seems to be acceptable when a static air overlay is in position. However, the score of 17.1% development (incidence) of pressure ulcers in the foam group may stress the need of repositioning when using only this type of mattress.

Primary study

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Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial).

Authors Ohura T , Nakajo T , Okada S , Omura K , Adachi K
Journal Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
Year 2011
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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The objective of this study was to evaluate the effects of nutrition intervention on nutritional states and healing of pressure ulcers by standardizing or unified factors including nursing, care and treatment in a multicenter open randomized trial. Tube-fed patients with Stage III-IV pressure ulcers were selected. The control group (30 patients) received the same nutrition management as before participating in this trial, whereas the intervention group (30 patients) was given calories in the range of Basal Energy Expenditure (BEE) × 1.1 × 1.3 to 1.5. The intervention period was 12 weeks. The efficacy and safety were evaluated based on the nutritional states and the sizes of ulcers (length × width), and on the incidence of adverse events related to the study, respectively. The calories administered to the control and intervention groups were 29.1±4.9 and 37.9±6.5 kcal/kg/day, respectively. Significant interactions between the presence or absence of the intervention and the intervention period were noted for nutritional states ( p&lt;0.001 for body weight, p&lt;0.05 for prealbumin). Similarly, the size of ulcers differed significantly between subjects in the intervention group and in the control group ( p&lt;0.001). The results suggest that nutrition intervention could directly enhance the healing process in pressure ulcer patients.

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A randomised controlled clinical trial of repositioning, using the 30° tilt, for the prevention of pressure ulcers.

Authors Moore Z , Cowman S , Conroy RM
Journal Journal of clinical nursing
Year 2011
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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BACKGROUND: Pressure ulcers are common, costly and impact negatively on individuals. Pressure is the prime cause, and immobility is the factor that exposes individuals to pressure. International guidelines advocate repositioning; however, there is confusion surrounding the best method and frequency required. DESIGN: A pragmatic, multi-centre, open label, prospective, cluster-randomised controlled trial was conducted to compare the incidence of pressure ulcers among older persons nursed using two different repositioning regimens. METHOD: Ethical approval was received. Study sites (<i>n</i> = 12) were allocated to study arm using cluster randomisation. The experimental group (<i>n</i> = 99) were repositioned three hourly at night, using the 30<i>°</i> tilt; the control group (<i>n</i> = 114) received routine prevention (six-hourly repositioning, using 90<i>°</i> lateral rotation). Data analysis was by intention to treat; follow-up was for four weeks. RESULTS: All participants (<i>n</i> = 213) were Irish and white, among them 77% were women and 65% aged 80 years or older. Three patients (3%) in the experimental group and 13 patients (11%) in the control group developed a pressure ulcer (<i>p</i> = 0·035; 95% CI 0·031–0·038; ICC = 0·001). All pressure ulcers were grade 1 (44%) or grade 2 (56%). Mobility and activity were the highest predictors of pressure ulcer development (β = −0·246, 95% CI = −0·319 to −0·066; <i>p</i> = 0·003); (β = 0·227, 95% CI = 0·041–0·246; <i>p</i> = 0·006). CONCLUSION: Repositioning older persons at risk of pressure ulcers every three hours at night, using the 30<i>°</i> tilt, reduces the incidence of pressure ulcers compared with usual care. The study supports the recommendations of the 2009 international pressure ulcer prevention guidelines. Relevance to clinical practice: An effective method of pressure ulcer prevention has been identified; in the light of the problem of pressures ulcers, current prevention strategies should be reviewed. It is important to implement appropriate prevention strategies, of which repositioning is one. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

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An RCT to determine the effect of a heel elevation device in pressure ulcer prevention post-hip fracture.

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Journal Journal of wound care
Year 2011
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This article is included in 3 Systematic reviews Systematic reviews (3 references)

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OBJECTIVE: A randomised controlled trial set out to determine whether there are differences between complete offloading and standard care in terms of the number of new pressure ulcers (PUs) developing on the heels of older patients with fractured hips and the number or severity of new PUs on other areas of their bodies. METHOD: Patients aged over 65 years in a fracture trauma unit with fractured hips were randomly allocated to receive heel elevation (DM Systems, Evanston, Illinois) plus pressure-redistributing support surface or standard care (pressure-redistributing support surface alone). Exclusion criteria included existing heel damage. Patients were assessed on pre- and postoperative days for the occurrence of new pressure damage. Patients completed a satisfaction questionnaire at discharge. RESULTS: 119 patients were recruited into the control group and 120 into the intervention group. Independent t-tests and chi-squared analysis showed both groups were comparable at baseline. Thirty-one subjects (26%) in the control group developed PUs compared with eight in the intervention group (7%, p &lt; 0.001). No subjects in the intervention group developed a PU on their ankles, feet or heels, whereas 29 subjects in the control group did (p &lt; 0.001). Kaplan-Meier survival curves indicated that subjects in the control group were more likely than those in the intervention group to suffer pressure damage at all time points (p = 0.001). A sensitivity analysis showed that when subjects lost to follow-up were assigned the worse outcome (PU positive) those in the intervention group were still less likely to develop PUs than the control group (p = 0.001). The offloading device was rated as comfortable overall by 59% of subjects. CONCLUSION: The findings suggest that offloading reduces the incidence of heel ulcers.

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Specific nutritional support accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients.

Journal Nutrition (Burbank, Los Angeles County, Calif.)
Year 2010
Links Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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ObjectiveWe investigated the potential of a high-protein, arginine- and micronutrient-enriched oral nutritional supplement (ONS) to improve healing of pressure ulcers in non-malnourished patients who would usually not be considered for extra nutritional support.MethodsForty-three non-malnourished subjects with stage III or IV pressure ulcers were included in a multicountry, randomized, controlled, double-blind, parallel group trial. They were offered 200 mL of the specific ONS or a non-caloric control product three times per day, in addition to their regular diet and standard wound care, for a maximum of 8 wk. Results were compared with repeated-measures mixed models (RMMM), analysis of variance, or Fisher's exact tests for categorical parameters.ResultsSupplementation with the specific ONS accelerated pressure ulcer healing, indicated by a significantly different decrease in ulcer size compared with the control, over the period of 8 wk (P &lt;/= 0.016, RMMM). The decrease in severity score (Pressure Ulcer Scale for Healing) in the supplemented group differed significantly (P &lt;/= 0.033, RMMM) from the control. Moreover, significantly fewer dressings were required per week in the ONS group compared with the control (P &lt;/= 0.045, RMMM) and less time was spent per week on changing the dressings (P &lt;/= 0.022, RMMM). At the end of the study, blood vitamin C levels had significantly increased in the ONS group compared with the control (P = 0.015, analysis of variance).ConclusionSpecific nutritional supplementation accelerated healing of pressure ulcers and decreased wound care intensity in non-malnourished patients, which is likely to decrease overall costs of pressure ulcer treatment.

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A randomized clinical trial on preventing pressure ulcers with wheelchair seat cushions

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Journal Journal of the American Geriatrics Society
Year 2010
Links Pubmed DOI PubMed Central

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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Objectives: To determine the efficacy of skin protection wheelchair seat cushions in preventing pressure ulcers in the elderly nursing home population. Design: Clinical trial with participants assigned at random to a skin protection or segmented foam cushion. Two hundred thirty-two participants were recruited between June 2004 and May 2008 and followed for 6 months or until pressure ulcer incidence. Setting: Twelve nursing homes. Participants: Nursing home residents aged 65 and older who were using wheelchairs for 6 or more hours per day and had a Braden score of 18 or less and a combined Braden activity and mobility score of 5 or less. Participants were recruited from a referred sample. INTERVENTION: All participants were provided with a fitted wheelchair and randomized into skin protection (SPC, n=113) or segmented foam (SFC, n=119) cushion groups. The SPC group received an air, viscous fluid and foam, or gel and foam cushion. The SFC group received a 7.6-cm crosscut foam cushion. Measurements: Pressure ulcer incidence over 6 months for wounds near the ischial tuberosities (IT ulcers) were measured. Secondary analysis was performed on combined IT ulcers and ulcers over the sacrum and coccyx (sacral ulcers). Results: One hundred eighty participants reached a study end point, and 42 were lost to follow-up. Ten did not receive the intervention. There were eight (6.7%) IT ulcers in the SFC group and one (0.9%) in the SPC group (P=.04). There were 21 (17.6%) combined IT and sacral ulcers in the SFC group and 12 (10.6%) in the SPC group (P=.14). Conclusion: Skin protection cushions used with fitted wheelchairs lower pressure ulcer incidence for elderly nursing home residents and should be used to help prevent pressure ulcers. © 2010, The American Geriatrics Society.

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Efficacy and safety of ornithine alpha-ketoglutarate in heel pressure ulcers in elderly patients: results of a randomized controlled trial.

Journal The journal of nutrition, health & aging
Year 2009
Links Pubmed DOI

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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Objective: Pressure ulcers affect predominantly the elderly and nutritional status is a known risk factor. Guidelines on pressure ulcers provide recommendation on nutritional management. Ornithine alpha-ketoglutarate (OKG) is an adjuvant treatment in undernourished elderly patients or in patients with hypercatabolism states. It is a precursor of different amino-acids which play a role in the process of healing. The objective of the study is to determine the efficacy of OKG on pressure ulcer area reduction after six weeks of treatment. Design: Multi-centre, international, randomized, comparative, double blind, parallel groups, placebo-controlled study. Participants: 160 patients (ITT population) aged over 60 years with a heel pressure ulcer at stage II or III. Intervention: Patients received OKG (n=85) or placebo (n=75) once a day for 6 weeks. Measurements: Ulcer area was measured each week, using a tracer. The primary endpoint was the percentage reduction of the surface at the final visit: [(Wound areatn - Wound areat0)/ (Wound areat0)]. Results: At inclusion, ulcer area distribution deviated from normal distribution (median ulcer area OKG 6.6cm2, placebo 3.9 cm2, p=0.044, Mann-Whitney test). As healing is strongly related to baseline ulcer area, the abnormal distribution was a major bias. Therefore it was decided to perform the analysis on 2 sub-groups of patients according to the mean ulcer area, i.e. above or below 8cm2. The mean wound area reduction for baseline area ≤ 8 cm 2 are -59.5 ± 71.4% and -54.0 ± 69.0% for the OKG group and placebo groups respectively (p=0.477, Mann-Whitney test). In the group with baseline pressure ulcer area > 8 cm2 no between group differences on either parameter was detected. When closure rate is considered, a significant difference in favor of OKG group is observed (- 0.07 cm 2/day in the OKG group and - 0.04 cm2/day in the placebo groups respectively p=0.007, Mann-Whitney test). Thirty serious adverse events were reported in 28 patients (15 allocated to OKG and 13 to placebo). None of them was considered treatment related. Conclusion: This clinical trial supports a potential benefit of OKG 10g daily in the subgroup of patients with pressure ulcers ≤ 8 cm2 surface area in elderly population when associated with debridement together with wound management according to pressure ulcer guidelines. However this study highlights methodological difficulties to perform clinical trials in old-old patients that may affect the robustness of the results for this type of study. The Journal of Nutrition, Health & Aging©.