Status:
COMPLETED
Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer
Lead Sponsor:
Belgium Health Care Knowledge Centre
Conditions:
Pressure Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to determine if silicone adhesive multilayer foam dressings applied to the sacrum, heels and greater trochanter in addition to standard prevention reduce pressure ulcer ...
Detailed Description
A multicentre randomised controlled open label parallel group medical device trial in approximately 8 hospitals in Belgium. Patients will be randomly allocated to three study arms based on a 1:1:1 al...
Eligibility Criteria
Inclusion
- At risk for pressure ulcer development based on Braden risk assessment (Braden score ≤17).
- Admitted to hospital within the previous 48 hours. Note: Not more than 25% of patients per site should be recruited at ICU wards.
- Skin at sacrum is assessable and there is no clinically relevant incontinence- associated dermatitis (IAD\*) or another skin condition that would be a contra-indication for the application of the devices under study, and there is no pressure ulcer category II or worse present.
- \*clinically relevant IAD is defined as any of the 4 categories described in the publication http://users.ugent.be/\~dibeeckm/globiadnl/nlv1.0.pdf
- For at least 3 of the following 4 skin sites (heel left, heel right, greater trochanter left, greater trochanter right) one of the following two conditions should apply:
- \- A study dressing can be applied as prevention of a pressure ulcer category II or worse at that skin site (there is no contra-indication)
- OR
- \- There is already a pressure ulcer category II or worse at that skin site.
- Written informed consent by the patient or his/her legal representative.
Exclusion
- Aged \< 18 years.
- The length of stay counting from first day of admission in one or (if the patient is transferred to another ward) more participating wards is \< 7 days.
- Both heels amputated
- Previously known/documented allergy for substances used in the devices under study.
- A clinical condition not allowing participation in a clinical study.
- Participation in another interventional clinical trial.
- Patients who exceptionally receive or are planned to receive a dressing for the prevention of pressure ulcers at sacrum, heels and trochanters based on best medical judgment and outside of the surgery setting.
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
1634 Patients enrolled
Trial Details
Trial ID
NCT03442777
Start Date
February 8 2018
End Date
December 31 2018
Last Update
April 26 2021
Active Locations (8)
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1
OLV Aalst
Aalst, Belgium, 9300
2
AZ Maria Middelares Ghent
Ghent, Belgium, 9000
3
University of Ghent
Ghent, Belgium, 9000
4
UZ Brussel
Jette, Belgium, 1090