Objective: To determine whether multilayer silicone foam dressings can prevent pressure ulcers arising in the sacrum and coccyx of patients with persistent severe diarrhea and/or fragile skin. Approach: This randomized, 14-day controlled trial included 600 hospitalized patients with persistent severe diarrhea and/or fragile skin who were at high risk of developing pressure ulcers. All participants were enrolled from three Japanese institutions. Participants meeting all inclusion and exclusion criteria were randomized using the Excel program to receive standard care (control; n = 300) recommended by Japanese guidelines or multilayer silicone foam dressings applied to the sacrum and coccyx (intervention; n = 300). Results: Significantly more participants in the control than the intervention group developed pressure ulcers (22 vs. 5, p = 0.001). Innovation: The incidence of pressure ulcers remains high in hospitalized patients at high risk of developing pressure ulcers. The present findings might contribute to novel preventive strategies for patients at high risk of developing pressure ulcers. Conclusion: Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.
Keywords: coccyx; diarrhea; sacrum; skin fragility.