The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.
Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.
Aarhus Universitetshospital
Aarhus, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Odense Universitets Hospital
Odense, Denmark
Pain Relief
The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.
Time frame: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)
Pain Intensity (PI) Change
Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).
Time frame: Change from baseline in Pain Intensity (PI) on day 4 evening
Change From Baseline in Ulcer Area
Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)
Time frame: Change from baseline to end of trial (day 43)
Adverse Events
Number of Adverse events reported which were evaluated to be related or possible related to the device
Time frame: Continuously from start of treatment to end of trial (day 43)
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CHU de Brest
Arras, France
CHU de Nancy - Hôpital Fournier
Nancy, France
Department for Dermatology, University School of Medicine
Essen, Germany
Georg-August-Universität Göttingen
Göttingen, Germany
Klinik für Dermatologie und Venerologie
Hanover, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany
Dr. Renzo Bause Praxis
Lüdenscheid, Germany
...and 3 more locations