KCE-16012: Anwendung eines Verbands aus mehrschichtigem Schaumstoff mit Silikonkleber zur Prävention von Dekubituswunden bei stationären Patienten

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)

Participants (P)

Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development

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).

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).

Outcome (O)

Trial Design

Multicentre randomised open label parallel group medical device trial

Sample Size

1662 patients in approximately 8 centres

Trial duration

2 years

Budget

2.750.000€ (incl. VAT)

Status

Closed - follow up complete

Sponsor

KCE – Belgium Health Care Knowledge Centre

Chief Investigator

Prof Dr Dimitri Beeckman
Department of Public Health
University Centre for Nursing and Midwifery, Ghent University

Trial coordinator

Bénédicte Manderlier
Department of Public Health
University Centre for Nursing and Midwifery, Ghent University

External Partners

DICE NV/SA
Koning Albertlaan 160
B-1082 Brussels, Belgium