Preventive Effect of a Microclimate-Regulating System on Pressure Ulcer Development: A Prospective, Randomized Controlled Trial in Dutch Nursing Homes

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Abstract

OBJECTIVE:

Prevention of pressure ulcers (PrUs) is based on relieving pressure, diminishing shear stress, and controlling the skin’s microclimate. Based on the recommendations in the most recent guideline for prevention of PrUs, a pressure-relieving, shear stress–diminishing, and microclimate-controlling skin interface multilayer support system (Bedcare; Sense Textile, ‘s-Hertogenbosch, the Netherlands) has been developed for use on top of a viscoelastic foam mattress (Formafoam, Kabelfabriek Eupen, Belgium). The aim of this study was to test the PrU preventive effect of this system compared with a viscoelastic foam mattress alone.

METHODS:

A multicenter, prospective, randomized controlled trial was executed in 21 nursing homes in the Netherlands. Residents with a Braden score less than 16, a life expectancy of more than 3 months, and no PrUs during the last 3 months were asked to participate and included after informed consent. Residents were divided into 2 groups. The control group received a new high-quality viscoelastic foam mattress covered with a cotton sheet. The intervention group received the same new mattress, in combination with the newly developed multilayer system. Research nurses followed the participating residents for 12 weeks. The outcome parameter was the development of PrUs.

RESULTS:

Two hundred six residents participated in the study. Both groups had comparable demographics (eg, age, Braden score, care dependency, incontinence). In the control group, 5% of the residents developed a category 2, 3, or 4 PrU, and 9% in the intervention group did. These results were not statistically significant.

CONCLUSIONS:

This study shows that the multilayer system (Mini Overlay System, barrier mattress cover, and Stay and Transfer Sheet), when used as an integral system and in combination with a viscoelastic foam mattress, has no added value over the viscoelastic foam mattress/cotton sheet.

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