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

Beeckman, Dimitri, Visiting Professor, 1982- (författare)
Örebro universitet,Institutionen för hälsovetenskaper,Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium; School of Nursing & Midwifery, Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland
Fourie, A. (författare)
Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium
Raepsaet, C. (författare)
Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium
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Van Damme, N. (författare)
Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium
Manderlier, B. (författare)
Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium
De Meyer, D. (författare)
Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium
Beele, H. (författare)
Wound Care Centre, Ghent University, Belgium
Smet, S. (författare)
Wound Care Centre, Ghent University, Belgium
Demarré, L. (författare)
AZ Sint-Elisabeth, Zottegem, Oost-Vlaanderan, Belgium
Vossaert, R. (författare)
AZ Sint-Elisabeth, Zottegem, Oost-Vlaanderan, Belgium
de Graaf, A. (författare)
Wound Care Support Team, Nursing Centre of Excellence, University Hospitals of Leuven, Belgium
Verhaeghe, L. (författare)
AZ Maria Middelares, Ghent, Belgium
Vandergheynst, N. (författare)
AZ Maria Middelares, Ghent, Belgium
Hendrickx, B. (författare)
University Hospital of Brussel (UZB), Department of Plastic Surgery, Brussel, Belgium
Hanssens, V. (författare)
University Hospital of Brussel (UZB), Department of Plastic Surgery, Brussel, Belgium
Keymeulen, H. (författare)
OLV Ziekenhuis Aalst, Aalst, Oost-Vlaanderan, Belgium
Vanderwee, K. (författare)
OLV van Lourdes Ziekenhuis Waregem, Waregem, West-Vlaanderan, Belgium
Van De Woestijne, J. (författare)
AZ Groeninge, Kortrijk, West-Vlaanderan, Belgium
Verhaeghe, S. (författare)
Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium
Van Hecke, A. (författare)
Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium
Savoye, I. (författare)
Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium
Harrison, J. (författare)
Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium
Vrijens, F. (författare)
Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium
Hulstaert, F. (författare)
Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium
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 (creator_code:org_t)
2020-12-28
2021
Engelska.
Ingår i: British Journal of Dermatology. - : Blackwell Science Ltd.. - 0007-0963 .- 1365-2133. ; 185:1, s. 52-61
Relaterad länk:
https://doi.org/10.1...
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https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • BACKGROUND: Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs).OBJECTIVES: Determine if silicone foam dressings in addition to standard prevention reduce PU incidence category 2 or worse compared to standard prevention alone.METHODS: Multicentre, randomised controlled, medical device trial conducted in eight Belgian hospitals. At risk adult patients were centrally randomised (n=1633) to study groups based on a 1:1:1 allocation: experimental group 1 (n=542) and 2 (n=545) - pooled as the treatment group - and the control group (n=546). Experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on these body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU category 2 or worse at these body sites.RESULTS: In the intention-to-treat population (n=1605); 4.0% of patients developed PUs category 2 or worse in the treatment group and 6.3% in the control group (RR=0.64, 95% CI 0.41 to 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 to 0.98, P=0.04). Heel PUs occurred in 1.4% and 1.9% of patients in the treatment and control group respectively (RR=0.76, 95% CI 0.34 to 1.68, P=0.49).CONCLUSIONS: Silicone foam dressings reduce the incidence of PUs category 2 or worse in hospitalised at-risk patients when used in addition to standard of care. Results show a decrease for sacrum, but no statistical difference for heel/trochanter areas.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Surgery (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Dermatologi och venereologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Dermatology and Venereal Diseases (hsv//eng)

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