Effectiveness of Multilayered Polyurethane Foam Dressings to Prevent Hospital-Acquired Sacral Pressure Injuries in Patients With Hip Fracture: A Randomized Controlled Trial.

PURPOSE: The purpose of this study was to determine the effectiveness of a multilayered polyurethane foam dressing applied within 24 hours of hospital admission compared with standard preventive pressure injury (PI) care in reducing sacral PI occurrence in older patients with hip fractures. DESIGN: Open-label, parallel-group, 2-arm, superiority trial. SUBJECTS AND SETTING: The sample comprised older patients aged 69 to 97 years admitted to a 1500-bed university hospital in Bologna, Italy, for hip fracture surgery. METHODS: Patients were randomly allocated to an intervention or control group. Both groups received standard evidence-based PI preventive care in accordance with National Pressure Ulcer Advisory Panel guidelines. In addition, patients in the intervention group received a single 12.9 × 12.9-cm multilayered polyurethane foam dressing shaped for the sacrum area applied within 24 hours of hospital admission. Bivariate analysis on primary and secondary outcomes and baseline characteristics was performed to compare group differences, and a survival analysis was used to determine the difference in PI incidence rates per group. RESULTS: Sixty-eight patients completed the trial; 34 patients were allocated to the intervention group and 34 patients to the control group. A trend toward significance was observed for sacral PI occurrence in the intervention group (intervention: 20.6%; control: 2.9%; P = .054). The foam dressing allowed significantly longer time (days) to PI occurrence (intervention: 5.9 ± 1.60; control: 2.7 ± 0.96; P = .003). CONCLUSIONS: These findings suggest that multilayered polyurethane foam dressings are not superior to the standard preventive PI care alone and should be used with caution, especially when multiple dressing changes may occur. Further exploration of the role of multilayered polyurethane foam dressings in preventing PI development is warranted.

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).