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A multicentre prospective randomised controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents [with consumer summary] |
Beeckman D, Serraes B, Anrys C, van Tiggelen H, van Hecke A, Verhaeghe S |
International Journal of Nursing Studies 2019 Sep;97:105-113 |
clinical trial |
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Pressure ulcers are a global issue and substantial concern for healthcare systems. Various types of support surfaces that prevent pressure ulcer are available. Data about the effectiveness and cost of static air support surfaces and alternating air pressure mattresses is lacking. OBJECTIVES: To compare the effectiveness and cost of static air support surfaces versus alternating air pressure support surfaces in a nursing home population at high risk for pressure ulcers. DESIGN: Prospective, multicentre, randomised controlled clinical, non-inferiority trial. SETTING: Twenty-six nursing homes in Flanders, Belgium. PARTICIPANTS: A consecutive sample of 308 participants was selected based on the following eligibility criteria: high risk for pressure ulcer and/or with category 1 pressure ulcer, being bedbound and/or chair bound, aged > 65 years, and use of an alternating air pressure mattress. METHODS: The participants were allocated to the intervention group (n = 154) using static air support surfaces and the control group (n = 154) using alternating air pressure support surfaces. The main outcome measures were cumulative incidence and incidence density of the participants developing a new category II to IV pressure ulcer within a 14-day observation period, time to develop a new pressure ulcer, and purchase costs of the support surfaces. RESULTS: The intention-to-treat analysis revealed a significantly lower incidence of category II to IV pressure ulcer in the intervention group (n = 8/154, 5.2%) than in the control group (n = 18/154, 11.7%) (p = 0.04). The median time to develop a pressure ulcer was significantly longer in the intervention group (10.5 days, interquartile range (IQR) 1 to 14) than in the control group (5.4 days, IQR 1 to 12; p = 0.05). The probability to remain pressure ulcer free differed significantly between the two study groups (log-rank X2 = 4.051, df = 1, p = 0.04). The overall cost of the mattress was lower in the intervention group than in the control group. CONCLUSIONS: A static air mattress was significantly more effective than an alternating air pressure mattress in preventing pressure ulcer in a high-risk nursing home population. Considering multiple lifespans and purchase costs, static air mattresses were more cost-effective than alternating air pressure mattresses.
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