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.

The British Journal of Dermatology
D BeeckmanF Hulstaert

Abstract

Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). 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. 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. 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, ...Continue Reading

References

Apr 20, 2006·International Journal of Nursing Studies·Lisette SchoonhovenUNKNOWN prePURSE-study group
Jun 6, 2006·Health Technology Assessment : HTA·J NixonUNKNOWN PRESSURE Trial Group
Jan 7, 2011·BMJ Quality & Safety·Katrien VanderweeMicheline Gobert
Dec 4, 2012·Journal of Wound, Ostomy, and Continence Nursing : Official Publication of the Wound, Ostomy and Continence Nurses Society·Gary L GroveNancy I Koski
Jan 30, 2014·International Wound Journal·Michael ClarkNick Santamaria
Apr 12, 2015·International Journal of Nursing Studies·Liesbet DemarréDimitri Beeckman
Nov 3, 2016·American Journal of Critical Care : an Official Publication, American Association of Critical-Care Nurses·Peggy KalowesMelanie Li
Jan 5, 2018·Journal of Wound, Ostomy, and Continence Nursing : Official Publication of the Wound, Ostomy and Continence Nurses Society·Janet RamundoJoyce Pittman
Jun 21, 2019·Advances in Skin & Wound Care·Amit GefenNick Santamaria

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Citations

Mar 5, 2021·The British Journal of Dermatology·F Coyer
Sep 24, 2021·Journal of Wound Care·Nathalie FaucherBenoit Nicolas

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