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Randomized Controlled Trial
. 2021 Jul;185(1):52-61.
doi: 10.1111/bjd.19689. Epub 2020 Dec 28.

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

D Beeckman  1   2   3 , A Fourie  1 , C Raepsaet  1 , N Van Damme  1 , B Manderlier  1 , D De Meyer  1 , H Beele  4 , S Smet  4 , L Demarré  5 , R Vossaert  5 , A de Graaf  6 , L Verhaeghe  7 , N Vandergheynst  7 , B Hendrickx  8 , V Hanssens  8 , H Keymeulen  9 , K Vanderwee  10 , J Van De Woestijne  11 , S Verhaeghe  1 , A Van Hecke  1 , I Savoye  12 , J Harrison  12 , F Vrijens  12 , F Hulstaert  12
Affiliations
Randomized Controlled Trial

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

D Beeckman et al. Br J Dermatol. 2021 Jul.

Abstract

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.

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Figures

Figure 1
Figure 1
Interventions and procedures. IAD, incontinence‐associated dermatitis; PU, pressure ulcer.
Figure 2
Figure 2
Participant flowchart. PU, pressure ulcer.
See this image and copyright information in PMC

Comment in

References

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