The effectiveness of two silicone dressings for sacral and heel pressure ulcer prevention compared with no dressings in high‐risk intensive care unit patients: a randomized controlled parallel‐group trial

Abstract

Summary Background There is a high incidence of pressure ulcers in high‐risk settings such as intensive care. There is emerging evidence that the application of dressings to pressure ulcer predilection areas (sacrum and heels) improves prevention strategies. Objectives To determine whether preventive dressings, applied to the sacrum and heels of high‐risk patients in intensive care units, in addition to standard prevention, reduces the incidence of pressure ulcers. Methods Between June 2015 and July 2018, a randomized, controlled, two‐arm, superiority pragmatic study was performed with a concealed 1 : 1 allocation to the intervention and control group. Patients assigned to the intervention group had dressings applied to the sacrum and heels. Results In total, 7575 patients were screened for eligibility and 475 patients were included and allocated to both groups. Finally, 212 patients in the intervention group and 210 in the control group were analysed. The mean age was 63·5 years and the majority of patients were male (65·4%). The cumulative pressure ulcer incidence category II and above was 2·8% in the intervention, and 10·5% in the control group (P = 0·001). Compared with the control group, the relative risk in the intervention group was 0·26 [95% confidence interval (CI) 0·11–0·62] and the absolute risk reduction was 0·08 (95% CI 0·03–0·13). Conclusions The results indicate that the application of dressings, in addition to standard prevention, in high‐risk intensive care unit patients is effective in preventing pressure ulcers at the heels and sacrum. What's already known about this topic? Pressure ulcers are severe soft tissue injuries and wounds, which occur worldwide in all healthcare settings. Despite preventive interventions, pressure ulcers still develop. There is emerging evidence that dressings help to prevent pressure ulcers. What does this study add? The incidence of pressure ulcers in intensive care units among high‐risk patients remains high. The application of dressings to the sacrum and heels, in addition to standard preventive measures, reduces the relative and absolute risks for the development of pressure ulcers. The application of preventive dressings at the heels and sacrum seems to be feasible in intensive care settings. Linked Comment: Nixon. Br J Dermatol 2020; 183:200–201.

The biomechanical efficacy of a dressing with a soft cellulose fluff core in prophylactic use

“…If the more frequent RSB dressing changes will be applied in clinical practice, the RSB dressings will always be at their near-'new' condition, where they perform superiorly to the silicone-foam products in delivering skin and deeper tissue protection (Figures 7 and 8). Noteworthy is that any existing preventative dressing should be changed within a range of 3 to 7 days of use 5,7,8 and accordingly, the specific frequency of changes (within that relatively wide time interval) is also a trade-off (optimization) problem of maximising performances and still meeting cost-benefit goals. This aspect requires further research, including with respect to the RSB dressing.…”

“…• prophylactic dressings protect the sacrum of supine patients from pressure ulcers • a computer model was used to determine dry and moist sacral dressing performances • multiple sacral dressings were tested experimentally vs a new fluff core design • the contribution of each type of dressing to tissue load reduction was calculated • the fluff core dressing effectively protects sacral tissues and more so when new which can range between facilities and care settings (typically it is between 3 and 7 days. 5,7,8 The emerging field of prophylactic use of dressings is currently dominated by silicone-foam dressings which are composed of layers of different foams and silicone in a sandwich-like structure. Of note is that products in the silicone-foam category differ considerably in their shapes, thicknesses, and the thicknesses of the individual constituent layers, as well as in the specific types of foam materials used in each layer and their mechanical properties.…”

“…4 The latest large randomised clinical trial in prophylactic dressings, conducted in Germany and published after the Fulbrook 4 paper appeared, confirmed the above findings. 5 The latter work included 212 ICU patients in the intervention group (where dressings were applied to the sacrum and heels) and 210 other ICU patients in a control group (mean age of 63.5 years; the majority of patients, 65.4%, were males). The cumulative PU incidence of category-2 wounds and more severe ones was 2.8% in the intervention group, statistically significantly lower than the corresponding incidence of 10.5% in the control group.…”

Cost‐effectiveness of multi‐layered silicone foam dressings for prevention of sacral and heel pressure ulcers in high‐risk intensive care unit patients: An economic analysis of a randomised controlled trial

“…C, ICERs for additional use of sacrum dressings only population. 23 However, the observed effect sizes and consequently the ICERs might not be comparable to other ICUs.…”

Silicone dressings for pressure ulcer prevention

“…In this issue of the BJD , Hahnel et al . report further results from a randomized controlled trial . While adding 422 patients and an additional 28 category ≥ 2 pressure ulcer events (six dressing, 22 control) to the existing evidence, the trial by Hahnel et al .…”