Effectiveness of a multi-layer silicone-adhesive polyurethane foam dressing as prevention for sacral pressure ulcers in at-risk in-patients: Randomized controlled trial

Background: There is need for improvement in effective pressure ulcers preventive strategies. Objective: To study whether a multi-layer silicone-adhesive polyurethane foam dressing shaped for the sacrum prevents PUs development in addition to standard PU preventive care for at-risk hospitalized patients. Design: Open-label, parallel group, multi-center randomized controlled trial. Participants and setting: 709 in-hospital patients at risk for pressure ulcers from 25 medical, surgical, and intensive care units of 12 Italian hospitals. Methods: A multi-layer silicone-adhesive polyurethane foam was applied to the sacrum in addition to standard PUs preventive care in the intervention group. In the control group, standard preventive care alone, including systematic pressure ulcer risk assessment, skin assessment three times per day, routine positioning every 4 h, use of active support surface as appropriate, and incontinence skin care, was guaranteed. Primary outcome was incidence of sacral pressure ulcers of any stage at seven days from hospital admission. Secondary outcomes were incidence of sacral pressure ulcers ≥ II stage, number of days needed to PU development, number of skin adverse events due to the foam dressing, number of dressings used for each patient, number of withdrawing patients due to discomfort caused by the foam dressing. Participants were evaluated at baseline and at seven days. Results: In patients admitted to medical units, 15/113 controls and 4/118 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 9.2%; NNT for benefit 11, 95% CI 6 to 44). In patients admitted to surgical units, 21/144 controls and 8/142 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 8.9%; NNT for benefit 11 95% CI 6 to 49). Pressure ulcers incidence was not significantly different between the randomization arms (5.2% experimental vs 10.4% control, p = 0.141) in patients admitted to intensive care units. Overall, 46/358 (12.8%) controls and 17/351 (4.8%) in the intervention group developed sacral pressure ulcers (p<0.001; absolute reduction 8%; number needed to treat (NNT) for benefit 12, 95% CI 8 to 26). Incidence of sacral pressure ulcers ≥ II stage did not differ significantly between the two groups. No adverse skin reactions and discomfort attributable to the foam application were reported. Conclusion: A sacral multi-layer silicone-adhesive polyurethane foam in addition to standard preventive care is effective for pressure ulcers prevention in at-risk hospitalized patients admitted to medical and surgical units. Trial registration: ClinicalTrials.gov NCT03900455. The registration (April 1st, 2019) occurred before the first patient was enrolled (October 21st, 2019).