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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 *
Author(s) -
Beeckman D.,
Fourie A.,
Raepsaet C.,
Van Damme N.,
Manderlier B.,
De Meyer D.,
Beele H.,
Smet S.,
Demarré L.,
Vossaert R.,
Graaf A.,
Verhaeghe L.,
Vandergheynst N.,
Hendrickx B.,
Hanssens V.,
Keymeulen H.,
Vanderwee K.,
Van De Woestijne J.,
Verhaeghe S.,
Van Hecke A.,
Savoye I.,
Harrison J.,
Vrijens F.,
Hulstaert F.
Publication year - 2021
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.19689
Subject(s) - medicine , randomized controlled trial , relative risk , silicone , surgery , confidence interval , incidence (geometry) , population , chemistry , physics , environmental health , organic chemistry , optics
Summary 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 4·0% of patients in the treatment group and 6·3% in the control group [relative risk (RR) 0·64, 95% confidence interval (CI) 0·41–0·99, P = 0·04]. Sacral PUs were observed in 2·8% and 4·8% of the patients in the treatment group and the control group, respectively (RR 0·59, 95% CI 0·35–0·98, P = 0·04). Heel PUs occurred in 1·4% and 1·9% of patients in the treatment and control groups, respectively (RR 0·76, 95% CI 0·34–1·68, P = 0·49). 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.