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

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

Trial Description
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)

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)

Incidence rate during the study period (maximum 14 days for any individual patient) of at least one new pressure ulcer category II, III, IV, Unstageable, Deep Tissue Injury (DTI) (briefly referred to as pressure ulcers category II or worse) on sacrum, heels and hips (greater trochanter) as judged on site.

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

 

Trial team

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

 

 


 

Dokumente
Protocol Download here
SAP Download here
Report Download here
Publication Download here
Referenzen

ClinicalTrials.gov  NCT03442777

 

FINANZIERUNGSSCHEMA

Commissioning workstream 2016

Published on: 
2017/12/07