Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial

Background Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). Objectives To determine whether silicone foam dressings in addition to standard prevention reduce the incidence of PUs of category 2 or worse compared with standard prevention alone. Methods This was a multicentre, randomized controlled medical device trial conducted in eight Belgian hospitals. At-risk adult patients were centrally randomized (n = 1633) to study groups based on a 1 : 1 : 1 allocation: experimental groups 1 (n = 542) and 2 (n = 545) - pooled as the treatment group - and the control group (n = 546). The experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on the relevant body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU of category 2 or worse at the studied body sites. Results In the intention-to-treat population (n = 1605), PUs of category 2 or worse occurred in 4 center dot 0% of patients in the treatment group and 6 center dot 3% in the control group [relative risk (RR) 0 center dot 64, 95% confidence interval (CI) 0 center dot 41-0 center dot 99, P = 0 center dot 04]. Sacral PUs were observed in 2 center dot 8% and 4 center dot 8% of the patients in the treatment group and the control group, respectively (RR 0 center dot 59, 95% CI 0 center dot 35-0 center dot 98, P = 0 center dot 04). Heel PUs occurred in 1 center dot 4% and 1 center dot 9% of patients in the treatment and control groups, respectively (RR 0 center dot 76, 95% CI 0 center dot 34-1 center dot 68, P = 0 center dot 49). Conclusions Silicone foam dressings reduce the incidence of PUs of category 2 or worse in hospitalized at-risk patients when used in addition to standard of care. The results show a decrease for the sacrum, but no statistical difference for the heel and trochanter areas.