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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

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 standa...

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Detalles Bibliográficos
Autores principales: Beeckman, D., Fourie, A., Raepsaet, C., Van Damme, N., Manderlier, B., De Meyer, D., Beele, H., Smet, S., Demarré, L., Vossaert, R., de 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8359283/
https://www.ncbi.nlm.nih.gov/pubmed/33216969
http://dx.doi.org/10.1111/bjd.19689
Descripción
Sumario: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.