A medical device trial to evaluate the use of a silicone adhesive multilayer foam dressing as prevention for pressure ulcer development in hospitalised patients (KCE-16012)

Summary (French or Dutch)

Despite preventive measures, pressure ulcers occur in more than 1 in 10 hospitalised patients. Pressure ulcers vary from non-blanchable erythema to full thickness tissue loss with exposed bone, tendon or muscle. Pressure ulcers are caused by pressure or pressure combined with shear (for example due to sliding down in a seat). To prevent pressure ulcers, regular repositioning and floating heels were recommended. Next to this, a broad range of mattresses and cushions, with the aim of reducing the amount of pressure, are used. Recently, interest is growing in the use of foam dressings as an additional measurement to prevent pressure ulcers. Foam dressings act as a cushion, reduce pressure and shear, and absorb excessive moisture. Similar dressings are already being used for the treatment of a range of skin lesions. Available studies claim the promising effect of foam dressings in reducing pressure ulcer risk. However, most studies were of low quality and restricted to critically ill patients. Furthermore, the use of foam dressings for pressure ulcer prevention is associated with additional costs.

 

The objective of this study is to determine if silicone adhesive multilayer foam dressings applied to the sacrum, heels and hips (greater trochanter) in addition to hospital standard prevention protocol, reduce pressure ulcer incidence compared to standard pressure ulcer prevention alone, in at risk hospitalised patients.

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

Recruiting
 

 

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

 

Archemin BVBA
Lange Nieuwstraat 1
B-2800 Mechelen

UniWeb BVBA
‘s Herenweg 16
B-1860 Meise
 

Documents
Protocol Download here (not yet available)
Report Expected for July 2019
Publication Expected for September 2019
References

ClinicalTrials.gov  NCT03442777

 

Funding scheme

Commissioning workstream 2016

Published on: 
2017/12/07