KCE-16012: Anwendung eines Verbands aus mehrschichtigem Schaumstoff mit Silikonkleber zur Prävention von Dekubituswunden bei stationären Patienten
Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Title |
The use of a silicone adhesive multilayer foam dressing as an adjuvant prophylactic therapy for pressure ulcer prevention: a multicentre randomised open label parallel group medical device trial in hospitalised patients at risk of pressure ulcer development. (KCE-16012) |
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Participants (P) |
Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development |
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Intervention (I) |
Study arm 1: Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith & Nephew (Allevyn® brand). Study arm 2: Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand). |
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Control (C) |
Study arm 3: No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left). |
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Outcome (O) |
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Trial Design |
Multicentre randomised open label parallel group medical device trial |
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Sample Size |
1662 patients in approximately 8 centres |
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Trial duration |
2 years |
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Budget |
2.750.000€ (incl. VAT) |
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Status |
Closed - follow up complete |
Sponsor |
KCE – Belgium Health Care Knowledge Centre |
Chief Investigator |
Prof Dr Dimitri Beeckman |
Trial coordinator |
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External Partners |
DICE NV/SA |
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ClinicalTrials.gov NCT03442777